Clinician programmer system and method for calculating volumes of activation

ABSTRACT

A system and method for providing a volume of activation (VOA) of a stimulation electrode leadwire may include a processor that calculates a VOA for each of a plurality of sets of parameter settings of the leadwire, stores in a database each of the calculated VOAs in association with the respective set of parameter settings for which it was calculated, obtains a set of parameter settings of the leadwire for a stimulation, and determines a VOA for the obtained set of parameter settings based on the stored VOAs.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority to U.S. Provisional Patent ApplicationSer. No. 61/053,449, filed May 15, 2008, U.S. Provisional PatentApplication Ser. No. 61/055,398, filed May 22, 2008, U.S. ProvisionalPatent Application Ser. No. 61/079,362, filed Jul. 9, 2008, U.S.Provisional Patent Application Ser. No. 61/111,523, filed Nov. 5, 2008,U.S. Provisional Patent Application Ser. No. 61/113,927, filed Nov. 12,2008, and U.S. Provisional Patent Application Ser. No. 61/201,037, filedDec. 4, 2008, the disclosures of all of which are herein incorporated byreference in their entireties.

FIELD OF THE INVENTION

The present invention relates to a 3-D programming environment, e.g.,usable for an electrical stimulation system for one or more physiologicareas, such as neural, cardiac or one or more other areas of a mammalianbody, such as a human or other animal.

BACKGROUND

Deep brain stimulation (DBS), such as of the thalamus or basal ganglia,is a clinical technique for the treatment of disorders such as essentialtremor, Parkinson's disease (PD), and other physiological disorders. DBSmay also be useful for traumatic brain injury and stroke. Pilot studieshave also begun to examine the utility of DBS for treating dystonia,epilepsy, and obsessive-compulsive disorder. However, understanding ofthe therapeutic mechanisms of action remains elusive. The stimulationparameters, electrode geometries, or electrode locations that are bestsuited for existing or future uses of DBS also are unclear.

A DBS procedure typically involves first obtaining preoperative imagesof the patient's brain, such as by using a computed tomography (CT)scanner device, a magnetic resonance imaging (MRI) device, or any otherimaging modality. This sometimes involves first affixing to thepatient's skull spherical or other fiducial markers that are visible onthe images produced by the imaging modality. The fiducial markers helpregister the preoperative images to the actual physical position of thepatient in the operating room during the later surgical procedure.

After the preoperative images are acquired by the imaging modality, theyare then loaded onto an image-guided surgical (IGS) workstation, such asthe STEALTHSTATION® from the Surgical Navigation Technologies, Inc.(SNT) subsidiary of Medtronic, Inc., for example. Using the preoperativeimages being displayed on the IGS workstation, a neurosurgeon can selecta target region within the brain, an entry point on the patient's skull,and a desired trajectory between the entry point and the target region.The entry point and trajectory are typically carefully selected to avoidintersecting or otherwise damaging certain nearby critical brainstructures or vasculature.

In the operating room, the patient is immobilized and the patient'sactual physical position is registered to the preoperative imagesdisplayed on the IGS workstation, such as by using a remotely detectableIGS wand. In one example, the physician marks the entry point on thepatient's skull, drills a burr hole at that location, and affixes atrajectory guide device about the burr hole. The trajectory guide deviceincludes a bore that can be aimed using the IGS wand to obtain thedesired trajectory to the target region. After aiming, the trajectoryguide is locked to preserve the aimed trajectory toward the targetregion.

After the aimed trajectory has been locked in using the trajectoryguide, a microdrive introducer is used to insert the surgical instrumentalong the trajectory toward the target region of the brain. The surgicalinstrument may include, among other things, a recording electrodeleadwire, for recording intrinsic electrical brain signals; astimulation electrode leadwire, for providing electrical energy to thetarget region of the brain; or associated auxiliary guidewires or guidecatheters for steering a primary instrument toward the target region ofthe brain.

The recording electrode leadwire is typically used first to confirm, byinterpreting the intrinsic electrical brain signals, that a particularlocation along the trajectory is indeed the desired target region of thebrain. The stimulation electrode leadwire, which typically includesmultiple closely-spaced electrically independent stimulation electrodecontacts, is then introduced to deliver the therapeutic DBS to thetarget region of the brain. The stimulation electrode leadwire is thenimmobilized, such as by using an instrument immobilization devicelocated at the burr hole entry in the patient's skull, in order for theDBS therapy to be subsequently performed.

The subthalamic nucleus (STN) represents the most common target for DBStechnology. Clinically effective STN DBS for PD has typically usedelectrode contacts in the anterior-dorsal STN. However, STN DBS exhibitsa low threshold for certain undesirable side effects, such as tetanicmuscle contraction, speech disturbance and ocular deviation. Highlyanisotropic fiber tracks are located about the STN. Such nerve tracksexhibit high electrical conductivity in a particular direction.Activation of these tracks has been implicated in many of the DBS sideeffects. However, there exists a limited understanding of the neuralresponse to DBS. The three-dimensional (3-D) tissue medium near the DBSelectrode typically includes both inhomogeneous and anisotropiccharacteristics. Such complexity makes it difficult to predict theparticular volume of tissue influenced by DBS.

After the immobilization of the stimulation electrode leadwire, theactual DBS therapy is often not initiated until after a time period ofabout two-weeks to one month has elapsed. This is due primarily to theacute reaction of the brain tissue to the introduced DBS electrodeleadwire (e.g., the formation of adjacent scar tissue), andstabilization of the patient's disease symptoms. At that time, aparticular one or more of the stimulation electrode contacts is selectedfor delivering the therapeutic DBS, and other DBS parameters areadjusted to achieve an acceptable level of therapeutic benefit.

SUMMARY

Parameter selections for DBS and other forms of neuromodulation (centralnervous system and peripheral nervous system) are typically currentlyachieved via arbitrary trial-and-error, without visual aids of theelectrode location in the tissue medium or computational models of thevolume of tissue influenced by the stimulation.

A treating physician typically would like to tailor the DBS parameters(such as which one or more of the stimulating electrode contacts to use,the stimulation pulse amplitude, the stimulation pulse width, and/or thestimulation frequency) for a particular patient to improve theeffectiveness of the DBS therapy. This is a complex problem becausethere are several different DBS parameters than can be varied. Becauseselecting a particular DBS electrode contact and parameter combinationsetting is typically a trial-and-error process, it is difficult andtime-consuming and, therefore, expensive. Moreover, it may notnecessarily result in the best possible therapy or in avoiding theabove-mentioned undesirable side effects. Therefore, there is a need toprovide help to speed or otherwise improve this DBS parameter selectionprocess or to otherwise enhance DBS techniques. Additionally, there is aneed for a better interface via which to control the electrodeselections and values.

Example embodiments of the present invention provide a system andmethods for efficient parameter selection. The system and methods mayproduce visual aids that help in a DBS parameter selection process. Inan example embodiment of the present invention, a system and methoddetermines a Stimulation Field Model (SFM) representing a volume oftissue likely to be stimulated by input stimulation parameters of theDBS electrode(s). The SFM is also referred to as a Volume of Influence(VOI), Volume of Activation (VOA), or Volume of Tissue Activated (VTA).The VOA may be based on voltages of an Electrical Stimulation Field(ESF).

In an example embodiment, the VOA is calculated for a monopolarelectrode leadwire, where the current source is from one or morecontacts on the DBS electrode leadwire and the ground is at a casing ofan Implantable Pulse Generator (IPG) located some distance from the DBSleadwire. In another example embodiment, the VOA is calculated for abipolar electrode leadwire, where the current source is from one or morecontacts on the DBS electrode leadwire and the ground is at another oneor more contacts of the DBS electrode leadwire.

In an example embodiment of the present invention, a system and methodmay determine an optimal DBS parameter set for a desired VOA.

In an example embodiment of the present invention, a system and methodmay provide a graphical user interface (GUI) display on a user interfacemachine in which a user may view the generated VOAs. The user may setvarious DBS parameter combinations and view the predicted VOAs, so thatthe user can use the information to decide which parameters to setduring the brain stimulation. The display may illustrate, for example, aVOA and anatomical structures, and their overlap, for example asdescribed in U.S. Provisional Patent Application Ser. No. 61/079,362,filed Jul. 9, 2008, which is incorporated herein by reference. The usermay thereby determine whether an anatomical structure intended to beactivated is activated in a displayed VOA and/or whether anatomicalstructures for which activation is detrimental is activated in thedisplayed VOA, for example, as described in U.S. Provisional PatentApplication Ser. No. 61/055,398, filed May 22, 2008, which isincorporated by reference herein.

Example embodiments of the present invention provide a clinicianprogrammer system configured to import one or more medical images of apatient (e.g., MRI image, CT image, or other medical image or scan); touse the one or more medical images to create a patient brain anatomy(e.g., fitting the medical image to a pre-loaded brain anatomy, such asby using a best-fit technique); to display a 3-dimensional (3-D)rendition of one or more substructures of the patient's brain; to obtainmicroelectrode recording (MER) data and incorporate the MER data intothe 3-D rendition of the one or more substructures of the patient'sbrain; to predict one or more programming settings; to show a sideeffect of the one or more programming settings; to define a desired VOA(e.g., define the desired VOA on the 3-D rendition of the one or moresubstructures of the patient's brain); to define programming settingsusing the desired VOA defined on the 3-D rendition of the one or moresubstructures of the patient's brain; to obtain information from one ormore sensors located in the clinician programmer system or other systemcomponents (e.g., an implantable medical device (IMD), an IPG, a patientprogrammer module, a leadwire, an extension, or a burr-hole cap); toreceive electroencephalography (EEG) information; to receive videoinformation; to analyze received information; and/or to storeinformation for clinician review.

In an example embodiment, the clinician programmer system is configuredto program an IMD, such as an IPG DBS, or other patient application ortherapy. In an example embodiment, a system can include a clinicianprogrammer or a therapy delivery module, the clinician programmer moduleoptionally including at least one of a viewer/navigator or programmingsoftware.

In an example embodiment of the present invention, a method includes:receiving a stimulation parameter; calculating a VOA using thestimulation parameter and a model electrode leadwire including aplurality of model electrode leadwire contacts; displaying theelectrical stimulation field in relation to the model electrodeleadwire; adjusting, in response to a user input, the VOA; anddisplaying the adjusted VOA.

In a further example embodiment of the method: the adjusting in responseto the user input includes adjusting in response to at least one of adirectional user input and an amplitude user input; the directional userinput includes at least one input related to moving the VOA with respectto the model electrode leadwire or altering the shape of the VOA; andthe amplitude user input includes at least one of adjusting theamplitude of the stimulation and adjusting a size of the VOA.

In an example embodiment of the present invention, a method includes:delivering an electrical stimulation; calculating a VOA; receiving atleast one of a benefit and a side effect from the electricalstimulation; registering at least one of the side effect and the benefitwith the VOA; and displaying at least one of the side effect and thebenefit with respect to the VOA. The at least one of the side effect andthe benefit may be received as user input via a user interface of thesystem. For example, the physician may observe and enter into the systemcertain benefits and/or side effects resulting from a stimulation usinga certain set of stimulation parameters.

An example embodiment of the present invention is directed to aprocessor, which may be implemented using any conventional processingcircuit and device or combination thereof, e.g., a Central ProcessingUnit (CPU) of a Personal Computer (PC) or other workstation processor,to execute code provided, e.g., on a hardware-implementedcomputer-readable medium including any conventional memory device, toperform any of the methods described herein, alone or in combination.The memory device may include any conventional permanent and/ortemporary memory circuits or combination thereof, a non-exhaustive listof which includes Random Access Memory (RAM), Read Only Memory (ROM),Compact Disks (CD), Digital Versatile Disk (DVD), and magnetic tape.

An example embodiment of the present invention is directed to ahardware-implemented computer-readable medium, e.g., as described above,having stored thereon instructions executable by a processor to performthe methods described herein.

An example embodiment of the present invention is directed to a method,e.g., of a hardware component or machine, of transmitting instructionsexecutable by a processor to perform the methods described herein.

BRIEF DESCRIPTION OF THE DRAWINGS

The patent or application file contains at least one drawing executed incolor. Copies of this patent or patent application publication withcolor drawing(s) will be provided by the Office upon request and paymentof the necessary fee.

In the drawings, which are not necessarily drawn to scale, like numeralsmay describe similar components in different views. Like numerals havingdifferent letter suffixes may represent different instances of similarcomponents. The drawings illustrate generally, by way of example, butnot by way of limitation, various embodiments discussed in the presentdocument.

FIGS. 1 a-1 b illustrate generally examples of using retrospective datato generate and/or modify a patient atlas for use to tailor DBSparameters and/or monitor DBS therapy.

FIG. 2 illustrates generally an example of a system including aclinician programmer and an implantable medical device (IMD).

FIGS. 3 a-3 j illustrate generally examples of clinician programmeroutput.

FIG. 4 illustrates generally an example of a method including aproviding a standard follow-up.

FIG. 5 illustrates generally an example of a method including importingpre-surgical medical images, identify a target location, and plan a leadinsertion site through its territory.

FIG. 6 illustrates generally an example of a method including acquiringMER data, stimulating and confirmation lead location, and recording theresults.

FIG. 7 illustrates generally an example of a method including adjustingparameters to optimal field orientation.

FIG. 8 illustrates generally an example of an example of adjustingparameters based on data analysis.

FIGS. 9A-9B illustrate generally an example of deforming an image usingone or more node.

FIGS. 10A-10B illustrate generally an example of deforming an imageusing one or more boundary.

FIGS. 11-12 illustrate example screenshots of system output for patienthistory functions.

FIG. 13 is a flowchart that illustrates methods of generating VOAs inmonopolar and bipolar cases, according to example embodiments of thepresent invention.

FIG. 14 illustrates models of an axon, an array of points, andapplication of the model axon to the array of points, according to anexample embodiment of the present invention.

FIG. 15 illustrates passes in which SFMs are generated for the monopolarcase, according to an example embodiment of the present invention.

FIG. 16 illustrates passes via which SFMs are generated for the bipolarcase, according to an example embodiment of the present invention.

FIG. 17 is a diagram that illustrates a leadwire with electrode contactslocated rotationally about the leadwire, according to an exampleembodiment of the present invention.

FIG. 18 is a diagram that illustrates a cross sectional view of theleadwire shown in FIG. 17, according to an example embodiment of thepresent invention.

FIG. 19 shows a gradual and smooth adjustment of the field along the Xaxis, according to an example embodiment of the present invention.

FIG. 20 shows an adjustment along the X axis by transposing the fieldabout the Y axis, according to an example embodiment of the presentinvention.

FIG. 21 shows a rotational adjustment of the field allowing for movementof the stimulation field in both the X and Y axes, according to anexample embodiment of the present invention.

FIG. 22 shows 26 linear directional inputs for steering a field,according to an example embodiment of the present invention.

FIG. 23 illustrates an interface via which to control and view astimulation field about electrodes, according to an example embodimentof the present invention.

FIGS. 24A-B illustrate a 2 window concept for directional leadwirelocation, according to an example embodiment of the present invention.

FIGS. 25A-B illustrate a 2 triangle concept for directional leadwirelocation, according to an example embodiment of the present invention.

FIG. 26 shows an image set that can be displayed in the interfacescreen, according to an example embodiment of the present invention.

FIG. 27 is a flowchart that illustrates a method for selecting an atlas,according to an example embodiment of the present invention.

DETAILED DESCRIPTION System Components

FIG. 2 illustrates generally an example of a system 200 including aclinician programmer terminal 105. The clinician programmer terminal 105includes any suitably appropriate computing device or combination ofcomputing devices, a non-exhaustive list of which includes a desktopcomputer or other workstation, a laptop, notebook computer, tablet PC,and handheld. The clinician programmer terminal 105 can include anydevice configured to send, receive, analyze, compute, and/or displayinformation.

In an example, the clinician programmer terminal 105 may include amemory device and a processor. The memory device may be configured tostore, and the processor may be configured to run, software, such asclinician programming software. The memory device may also be used forstoring various information as described in detail below.

Method examples described herein can be machine or computer-implementedat least in part. Some examples can include a computer-readable mediumor machine-readable medium encoded with instructions operable toconfigure an electronic device to perform methods as described herein.An implementation of such methods can include code, such as microcode,assembly language code, a higher-level language code, or the like. Suchcode can include computer readable instructions for performing variousmethods. The code may form portions of computer program products.Further, the code may be tangibly stored on one or more volatile ornon-volatile computer-readable media during execution or at other times.These computer-readable media may include, but are not limited to, harddisks, removable magnetic disks, removable optical disks (e.g., compactdisks and digital video disks), magnetic cassettes, memory cards orsticks, RAM, ROM, and the like.

As shown in FIG. 2, the clinician programmer terminal 105 may be coupled(e.g., wirelessly, directly, etc.) to an IMD 110. For example, theclinician programmer terminal 105 may include a telemetry module 106.The telemetry module may be configured for wireless, electrical,optical, or other telemetry. In an example embodiment, the telemetrymodule 106 may include a universal serial bus (USB) dongle that attachesto the clinician programmer terminal 105 (e.g., used to communicate withthe IMD 110).

In an example embodiment, the IMD 110 may include an IPG, variousimplantable sensors, or other implantable energy delivery circuits. Inother examples, the clinician programmer terminal 105 may include or canbe communicatively coupled to other external devices, such as anexternal pulse generator (EPG), a patient programmer device, etc.

In example embodiments of the present invention, the clinicianprogrammer system may include one or more of the following: passwordprotection; data storage capabilities including storage and use ofpatient, physician, and device information, diagnostic tracking, usagestatistics, storage and usage of therapy information, user access, andprintable data recovery; support of IPG/EPG/PP capabilities; foreignlanguage support; 3-D visualization of stimulation field includingcapabilities for importing MRI/CT scans, a module(s) for automaticallymerging scans and allowing a user to manually verify, capabilities forlocating frame fiducials, an interface for manual selection of AnteriorCommissure (AC)—Posterior Commissure (PC), a 3-D stretchable/deformableatlas of the thalamus with defined substructures, basal ganglia andcerebellum, input MER tracks, translation of 3-D structures based onMER, placement of leadwire including x, y, z, arc, ring, and rotation;an interface for entering parameter data and capabilities for stretchingthe stimulation field; support for logging or displaying calculatedVOAs; and interpolation between different VOAs including linear ornonlinear, stored gradient fields, and choosing an isosurface ongradient.

Programmer Overview

FIG. 4 illustrates generally an example of a method 400 includingplanning a surgical case, implanting a leadwire, conductingpost-surgical follow-up, programming the IPG, and conducting standardfollow-up, according to an example embodiment of the present invention.

At step 405, the surgical case is planned. In certain examples, thesurgical planning can include pre-visualizing a surgical intervention,determining the area or location for intervention (e.g., an area or alocation of a brain), determining the amount of intervention (e.g.,determining the electrical or other stimulation or stimulationparameters), determining or planning a method or route for intervention,etc.

In an example, surgical planning for deep brain stimulation (or otherneurosurgery) can include taking, receiving, or importing one or moreimages (e.g., CT, MR, etc.) of the patient, including one or morepossible areas of intervention. In certain example embodiments of thepresent invention, the system is configured to generate and display a3-D model of one or more areas of the patient, e.g., using the one ormore images, or an existing 3-D model can be adapted to fit the one ormore areas of the patient, e.g., using the one or more images.

In an example, once created or adapted, the 3-D model can be used toplan a path or entry point for a proposed therapy or intervention. Incertain examples, the path can be planned to avoid entrance to,disturbance of, or damage to one or more areas of the brain orsurrounding tissue and vasculature, to achieve a desired efficacy, toavoid one or more predicted side effects, etc. In other examples, atleast one of a stimulation parameter or the path or entry point can beplanned or predicted based upon a desired intervention, stimulation, orother outcome.

At step 410, a leadwire is implanted. In an example, the leadwire can beimplanted using the planned surgical case or surgical planning. In anexample, the leadwire can be a stimulation leadwire. In other examples,features described herein with respect to a leadwire may be applied toother intervention or therapy devices, e.g., lesioning or therapydelivery devices, implanted instead of, or in conjunction with, thestimulation leadwire.

At step 415, post-surgical follow-up is conducted and an initialprogramming of the IPG is conducted. Further, a stimulation therapy maybe administered in accordance with therapy parameters of the initialprogramming. In an example, once the leadwire has been implanted, one ormore medical images can be taken to evaluate the location of theleadwire. In certain examples, a 3-D model can be created, using the oneor more medical images, and displayed to show the actual location of theleadwire or other implanted intervention or therapy device.

In certain examples, the actual leadwire location, path, or entry pointcan be compared to a planned, predicted, or desired leadwire location(e.g., the path or entry point planned during the surgical planning orthe plan surgical case step 405). For example, if it is determined thatthe actual leadwire location is different than the planned position, amodel of the leadwire relative to anatomical structures may beaccordingly modified.

In an example embodiment of the present invention, once the leadwire hasbeen implanted, a desired therapy, intervention, stimulation, or othertreatment can be predicted or computed at or for the actual leadwirelocation. In certain examples, the leadwire can include one or moreelectrodes in one or more locations. In this example, the prediction orcomputation of the desired therapy, intervention, stimulation, or othertreatment can include a prediction or computation of a direct effect(e.g., desired therapy, etc.), indirect effect (e.g., side effect,etc.), or other effect of the desired therapy, intervention, stimulation(e.g., including stimulation parameters), or other treatment at thelocation using the one or more electrodes or specific combinations ofthe one or more electrodes.

At step 420, standard follow-up is conducted. In certain examples, thestandard follow-up can include further imaging, one or more tests orexperiments, further programming of the IPG or EPG, analysis of recordeddata, and/or follow-up medical examinations or appointments.

In an example, one or more steps of method 400 can be completed usingthe clinician programmer terminal 105.

Modeling

In an example embodiment of the present invention, a system includes aclinician programmer system executing a clinician programmer softwaremodule configured to import one or more medical images of a patient,such as a patient's MRI or CT scans (pre-implant or post-implant). Theclinician programmer system may be configured to display the one or moremedical images, e.g., using a viewer/navigator module and GUI displaydevice coupled to the clinician programmer module.

In an example, the clinician programmer system may be configured tochange or alternate between different medical images, such as differentMRI or CT images or views. Further, the clinician programmer system maybe configured to display different brain slices to show differentsections, areas, slices, structures, or substructures of the brain orother parts of the nervous system being modeled.

In example embodiments of the present invention, the clinicianprogrammer system is configured to create, e.g., using one or moremedical images of the patient, a 3-D rendering of anatomicalsubstructures of the brain that, in certain examples, can be overlaidover appropriate sections of the one or more medical images stored,imported, or otherwise received by the clinician programmer system. Inan example, the 3-D rendering can include a scalable (e.g., stretchableor deformable) brain atlas. In an example, the stretchable or deformableatlas can include an atlas of a single brain, or a single atlas createdas an average of multiple brains. Alternatively, the system may beconfigured to select, from a multitude of atlases, a closest match to acurrent patient.

For example, as shown in FIG. 27, the system may, at step 2700, store inan atlas repository multiple 3-D atlases of individual brains (or otherphysiological area), e.g., corresponding to a patient population. Thesystem may further compute and/or store in the atlas repository at step2700 a statistical 3-D atlas constructed based on a combination of allof the stored multiple 3-D atlases. The system may further computeand/or store in the atlas repository at step 2700 statistical 3-Datlases, each constructed based on a respective combination of a subsetof all of the patient population atlases.

At step 2702, the system may compare image data and/or MER data of thesubject patient and the patients to whom the atlases of the atlasrepository correspond. For example, MRI or other image data of thepatient may be compared to image data of patients of the patientpopulation, or MER data of the patient may be compared directly to theatlases.

At step 2704, the system may select one of the atlases from the atlasrepository as a best fit atlas. The selection may be based onsimilarities between the image data and/or MER data determined in thecomparison step 2702.

At step 2706, the system may display the selected best fit atlas, whichmay be further deformed automatically or manually.

The clinician programmer system can be configured to automaticallyco-register, scale, and/or adjust the one or more medical images (e.g.,a MRI or a CT image); identify the AC, the PC, the AC/PC line, themidline, and/or other identifiable structure or landmark of the brain;calculate the mid-commissural point (MCP); and/or provide ventriclesegmentation or frame fiducial identification through an algorithmicprocess.

For example, one or more medical images of the patient can be uploaded.Then, using the one or more uploaded medical images, the AC/PC line canbe detected. In certain examples, the AC/PC line can be detectedmanually by a clinician. Alternatively, the system can automaticallydetect the AC/PC line. In an example, the AC/PC line, or otherinformation about the AC or PC, can be coordinated or detected inrelation to surgical hardware, such as a headframe or other surgicalmarker. Once the AC/PC line is detected, adjustments can be made to amodel or brain atlas to fit the one or more medical images. In anexample, the adjustments can include linear stretching to match thegeneral shape and size of the brain as shown in the one or more medicalimages, and further adjustments using the detected AC/PC line. In anexample, the linear adjustments can be made manually by a clinician orother user, or the linear adjustments can be made automatically usingone or more image processing techniques.

In an example embodiment, once the general shape of the model or brainatlas has been met, the system is configured for receiving input tostretch or deform at least a portion of the model or brain atlas tobetter fit certain structures or substructures that were not closely fitusing the automatic or manual linear adjustments. Alternatively oradditionally, the system may be configured to perform the additionalstretching or deformation of the at least a portion of the model orbrain atlas.

In an example embodiment, the system is configured to control thestretching or deforming of the model or brain atlas using one or morenodes or boundaries placed throughout at least a portion of the model orbrain atlas.

For example, if at least a portion of a patient's brain is abnormallyshaped or different than the base model or brain atlas (e.g., if aportion of the brain has been damaged or is otherwise different from thebase model or brain atlas), the at least a portion of the model or brainatlas (e.g., a structure, substructure, or other portion of the brain)can be stretched or deformed, while leaving the remainder of the modelor brain atlas, or a portion of the remainder of the model or brainatlas, unchanged. In an example, this can be accomplished using one ormore nodes or boundaries.

FIGS. 9A-9B illustrate generally an example of deforming an image usingone or more nodes. In an example embodiment of the present invention,the system provides for one or more nodes 900 to be located on the modelor brain atlas. For example, FIG. 9A shows four nodes 900. The one ormore nodes 900 can be manually added by a clinician or other user, orthe node 900 can be automatically placed on the model or brain atlas(e.g., a uniform distribution automatically placed across the slice orother view of the model or brain atlas). In an example, the clinician orother user can select a node 900 and move it to a location (e.g.,manually, such as by dragging the node 900 with a mouse or other inputdevice, by entering a location for the node 900 to be moved to, or byother input methods) in order to better fit the one or more medicalimages of the patient to the model or brain atlas. For example, FIG. 9Bshows the node 900 at the top-left corner of FIG. 9A being moved fromlocation 902 to location 904.

The system may be configured such that moving the node 900 causes thesystem to stretch, deform, or otherwise move the portion of the model orbrain atlas immediately under or in contact with the node 900, as wellas an area around the node. In certain examples, the area around thenode 900 is automatically set, or the area can be manually defined(e.g., larger or smaller). In an example embodiment, the system isconfigured with one or more modes, where a first mode corresponds to oneor more settings being in a default mode (e.g., automatic settings), andwhere a second mode corresponds to one or more settings being in amanual mode (e.g., clinician or other user defined settings).

In certain examples, the area that is stretched or deformed can belinearly deformed (e.g., the area closest to the node can be stretchedor deformed the same amount as, or a linear amount more or less than,the area farthest from the node), or the area that is stretched ordeformed can be nonlinearly deformed. Further, the amount ordistribution of the magnitude of the stretching or deforming can beautomatically set to a default amount, or manually set or adjusted by aclinician or other user.

FIGS. 10A-10B illustrate generally an example of deforming an imageusing one or more boundaries. In an example embodiment of the presentinvention, one or more boundaries can be placed on the model or brainatlas. In an example, a boundary can be defined using one or more nodes,or using some other method (e.g., a dashed line, etc.). In certainexamples, the boundary can define an area on the model or atlas thatwill (or conversely, that will not) be changed, stretched, deformed, orotherwise altered. Thus, the boundary can protect one or more areas thatdo not need to be changed, or it can define one or more areas that canbe changed.

In an example embodiment, the boundary can include a boundary around oneor more specific structures or substructures of the brain that can bemanually defined by a clinician or other user, or that can beautomatically defined (e.g., already defined in the model or brainatlas, or automatically detected and placed by the clinician programmersystem or other device, system, or method).

In an example embodiment, and as shown in FIGS. 10A-10B, two or moreboundaries can define a first area 10000, a second area 10002, and athird area 10004. The first area 10000 can be defined using a firstborder 10001. The first area 10000 can be defined as one that can bemoved, relocated, or otherwise altered. The third area 10004 can bedefined using a second border 10003 (e.g., the second border 10003coupled with one or more other boundaries, such as the edge of the modelor brain atlas or other boundary 10005). The third area 10004 can bedefined as one that cannot be moved, relocated, or otherwise altered.The second area 10002 can be defined as the area between the firstborder 10001 and the second border 10003 and can be defined as an areathat can be stretched or deformed (e.g., linearly or nonlinearly,automatically or manually set or adjusted) to accommodate the movement,relocation, or other alteration of the first area 10000. For example,FIG. 10B shows area 10000 shifted to the right as compared to itsposition in FIG. 10A, with a corresponding deformation of area 10002.

In an example embodiment of the present invention, the system isconfigured to automatically adjust a model or brain atlas according tospecific brain injuries or deformities.

FIG. 5 illustrates generally an example of a method 500, according to anexample embodiment of the present invention, including importingpre-surgical patient MR (or MRI) and CT scans, fitting patient scans toa pre-loaded best-fit atlas(es), identifying a target location within agraphical representation of a best-fit scan, and planning the leadinsertion site and trajectory.

At step 505, pre-surgical patient MR and CT scans are imported. In anexample, the MR and CT scans include at least one of MR, CT, or othermedical scan, image, or data. In an example, the scans are imported intothe clinician programmer system, such as into the clinician programmerterminal 105.

At step 510, patient scans are fit to pre-loaded best-fit atlases orscans. In certain examples, the patient scans can be automatically fit(e.g., by the clinician programmer system) to pre-loaded best-fitatlases or scans, or the patient scans can be manually fit (e.g., by auser) to pre-loaded best-fit atlases or scans.

In an example, once imported, the scans can be analyzed, such asautomatically by the clinician programmer system using image processingor other techniques or algorithms, for example, to automatically createa model (e.g., a 3-D model) of at least a portion of the patient's brainanatomy, including brain structures, substructures, or other anatomy, orto automatically fit a pre-loaded best-fit scan or preloaded model(e.g., a preloaded 3-D model, such as one of a plurality of stored 3-Dmodels) of the patient's brain anatomy. In other examples, the scans canbe analyzed, such as manually by a user, or a combination ofautomatically by the clinician programmer system or manually by theuser, to create a model of the patient's brain anatomy, or to fit apre-loaded best-fit scan or preloaded model of the patient's brainanatomy, such as a brain atlas.

At step 515, the target location for treatment is identified within thegraphical representation of the best-fit scan. In an example, the targetlocation can be identified by a clinician using the model or pre-loadedbest-fit scans. For example, the system may provide for receipt andprocessing of user input selecting a plurality of points within a 2-D or3-D model to outline a 2-D or 3-D target location. The system mayfurther provide for clicking and dragging upon one or more points of adisplayed target location to change its shape. Any suitably appropriateuser input device, e.g., a computer pen, a touch-sensitive screen, amouse, joystick, and/or other controller, may be used for obtaining theuser input.

In other examples, the target location can be identified or suggested bythe clinician programmer system, for example, using clinician input, thepatient's information (such as a patient disorder, patient history,etc.) population information (such as learned information from one ormore other patients).

At step 520, a lead insertion site and trajectory are planned. In anexample, the lead insertion site can be planned according to theidentified target location.

In an example embodiment of the present invention, the clinicianprogrammer system is configured to plan a surgical path for implantationof a stimulation leadwire using a head-frame (e.g., Lexcel), a framelesshead mount (e.g., Nexframe), or other surgical tool.

In an example embodiment of the present invention, the system isconfigured to receive information from a microelectrode, e.g., amicroelectrode recording (MER), including information about thetrajectories of each MER track into the brain or a log of criticalpoints on each track. In certain examples, the system receives MER dataentered manually by a user or automatically entered by receiving datadirectly from a MER system (e.g., the MER system including amicroelectrode coupled to a lead or other communicative element).

In an example embodiment, information detected at certain depths orlocations inside the brain can be used for indications of structure,substructure, boundaries, or other medical or location specificinformation. In an example, the system uses the information obtainedfrom the microelectrode, such as the critical points, to create or altera model or scalable atlas to create an accurate rendition of thepatient's brain or one or more substructures of the patient's brain.

FIG. 6 illustrates generally an example of a method 600 includingacquiring microelectrode recording (MER) data, confirming patient scanfit and location, inserting and rotating a directional leadwire to anoptimal position, stimulating and confirming location, and recordingresults from the stimulation and optimal electrode setting.

At step 605, MER data is acquired. Example embodiments provide for MERdata to be acquired, uploaded, input, or stored manually, such as by aclinician or other user, or automatically in the clinician programmersystem.

In an example embodiment, a microelectrode can include an electrodehaving a tip dimension small enough (e.g., less than 1 mm) to allownondestructive puncturing of a plasma membrane. The size of themicroelectrode can allow intracellular recording of resting and actionpotentials, the measurement of intracellular ion or pH levels, ormicroinjection.

In an example embodiment, the microelectrode can be inserted into thebrain, such as at a proposed or actual trajectory of a therapy deliveryor other device or at another area, and can be configured to receivephysiological information indicative of a location, structure, orsubstructure of the brain at which the microelectrode is located or withwhich the microelectrode is in contact.

At step 610, patient scan fit and location is confirmed. In an example,once acquired, the MER data can be used to, manually via an interface ofthe clinician programmer system or automatically, create, confirm, oradjust a model or best-fit scan of the patient's brain anatomy. Forexample, the scan fit performed at step 510 may be modified. Forexample, a light brain shift that occurs due to the DBS operation, e.g.,specifically the drilling of the burr hole, for which the brain atlasmay be corrected based on the MER data.

After confirmation, at step 615, the stimulation leadwire is insertedand, if necessary, the leadwire is rotated to an optimal position. In anexample, the optimal position can include a position predicted using theclinician programmer system, or a position selected by the clinician orother user.

In example embodiments of the present invention, the clinicianprogrammer system can receive post-operative medical images, e.g., toshow the exact location of an implanted stimulation leadwire. In certainexample embodiments, the system is configured to superimpose a model ofthe stimulation leadwire over the location of the implanted stimulationleadwire, and/or to adjust the scalable atlas to show the appropriaterendition of the patient's brain or one or more substructures of thepatient's brain.

Image Importation for Atlas Generation

In an example embodiment of the present invention, the creation oradjustment of a patient brain atlas may be performed with imagesobtained from external patient medical files recorded independent of anyDBS therapy procedures, including medical images taken prior to and/orsubsequent to the leadwire implantation. While FIGS. 1 a-1 b referspecifically to MRI and CT data, it will be appreciated, that imagesand/or data of other modalities, such as Functional Magnetic ResonanceImaging (fMRI), Diffusion Tensor Imaging (DTI), Positron EmissionTomography (PET), and/or X-ray, may be used.

FIG. 1 a illustrates generally an example of a method 1000 for usingretrospective data to create or modify a patient specific brain atlasfor use to tailor or otherwise alter or change one or more DBSparameters and/or for use to monitor or judge the efficacy or potentialfor improvement of an existing DBS or other therapy.

At step 1005, pre-operative magnetic resonance imaging (MRI) data of apatient is received. (Alternatively, a post-operative MRI image oranother pre- or post-operative medical image may be used.) In anexample, the pre-operative MRI data of the patient can include an MRIscan taken prior to implanting a lead or electrode in the patient'sbrain. In other examples, the pre-operative MRI data can include anystored or other MRI data in the patient's medical file or other storagelocation, or the MRI data can include other MRI data of the patientrecorded at some time in the patient's past. In an example embodiment,it is not required for the image to have been taken ir preparation forthe implantation of the leadwire. (Similarly, in an instance in which apost-operative MRI or other medical image is used, it is not requiredfor the post-operative medical image to have been taken in relation tothe implanted leadwire.) Thus, in an example embodiment, it is notrequired for any new MRI or other medical image data to be obtained forthis procedure or for these purposes. Instead, previously attained MRIor other medical imaging data may be used.

At step 1010, post-operative computed tomography (CT) data of a patientis received. In an example, the post-operative CT data of the patientcan include a CT scan taken following implantation of a leadwire in thepatient's brain. In other examples, the post-operative CT data caninclude any stored or other CT data in the patient's medical file orother storage location showing the implanted leadwire, or the CT datacan include other CT data of the patient recorded at some time in thepatient's past, following implantation of the leadwire. Thus, in exampleembodiments of the present invention, obtaining any new CT data for thisprocedure or for these purposes is not required. Instead, previouslyattained CT data may be used.

At step 1015, a leadwire is located, e.g., axially and/or rotationally,automatically or manually in the post-operative CT data. Once theleadwire is located, the implanted location of the lead or electrode canbe identified or recorded.

At step 1020, the location of the leadwire can be identified on thepre-operative MRI data, or other MRI data, using the located leadwire inthe post-operative CT data, or other CT data. Alternatively, thepost-operative or other CT data can be correlated, registered,co-registered, or otherwise morphed, changed, or altered, e.g., to thesame or similar view, plane, or other orientation as the MRI data, toidentify the location or placement of the identified lead or electrodeon the pre-operative or other MRI data.

At step 1025, a patient-specific brain atlas is created using thepre-operative or other MRI data having the identified lead.

Alternatively, the patient-specific brain atlas can be created using thepre-operative or other MRI data, and the lead location can be identifiedor placed on the patient-specific brain atlas using the locationidentified on the pre-operative or other MRI data.

FIG. 1 b illustrates generally an example of an alternative method 2000for using retrospective data to create or modify a patient specificbrain atlas for use to tailor or otherwise alter or change one or moreDBS parameters and/or for use to monitor or judge the efficacy orpotential for improvement of an existing DBS or other therapy.

At step 2005, pre-operative (or post-operative) MRI data of a patient isreceived.

At step 2010, a patient-specific brain atlas is created using thepre-operative MRI data. In other examples, the patient-specific brainatlas can be created using other MRI data or other medical images.

At step 2015, post-operative CT data of the patient is received.

At step 2020, a leadwire is located in the post-operative CT data.

At step 2025, the leadwire is identified in the patient-specific brainatlas using the located leadwire in the post-operative CT data.

In an alternative example embodiment, the leadwire may be located in anMRI image without use of CT data.

Locating Directional Leadwire

In an example embodiment of the present invention, a directionalleadwire can be located in a biological medium using one or moremechanical features or electrical features to locate the leadwire in amedical image, e.g., using software. The leadwire may include featuresas those described in U.S. patent application Ser. No. 12/029,141, filedFeb. 11, 2008, the entire disclosure of which is herein incorporated byreference in its entirety. In an example, the medical image can includeat least one of a fluoroscopy, a post-op MRI, and a post-op CT. In otherexamples, other imaging modalities may be used.

Generally, a directional leadwire can be located both axially androtationally. In an example, the leadwire can include a directionalelectrode and/or a locating feature on one side of the leadwire that isvisible under CT or MRI. A directional electrode is an electrode thatextends less than 360° about the body of the leadwire. If a post-op CTis used, the leadwire can be located relative to one or more targetedbrain structures by merging the post-op CT with the pre-op MRI, or viceversa.

In an example, the leadwire can be automatically located in a medicalimage. To determine the location of these electrodes, post-op images maybe segmented using one or more image segmentation algorithms, possiblyincluding a histogram-based and edge-detection method as a coarse firstpass to identify regions of interest in the CT volumes and templatematching and clustering techniques to segment the electrode from otherhigh intensity regions.

In addition, a locating feature may be incorporated into the leadwire toassist in discernment of its rotational location.

In an example, if MRI is used, a post-op MRI can be taken and the sameprocess can be used without merging the post-op CT. In this example, thepost-op MRI can be sufficient to locate the leadwire relative to thebrain structures, e.g., by automatically locating the leadwire in thepost-op MRI by identifying the artifact that is created during imaging.

An example embodiment of the present invention may include a two windowconcept for directional leadwire locating features as shown in FIGS.24A-B, for example, where bands include recessed portions.

Another example embodiment may include a two triangle concept fordirectional lead locating features as shown in FIGS. 25A-B. In otherexample embodiments, other shapes may be used. For example, other shapesmay be used. For example, the shapes may include components having aparticular orientation, such that the orientation of the shapes of thetwo markers may differ. According to these example embodiments, themarkers may be shapes that protrude from a band, rather than windows inone or more bands.

The angle at which these features are viewed under fluoro, CT, and/orMRI can tell the user the direction in which each electrode set ispointing.

In the embodiment providing the two triangle (or other shape, e.g.,including a protrusion) concept, the two triangles (or other shape) maybe identically shaped. This way, with rotation of the leadwire about thelongitudinal axis of the leadwire, the user can tell the direction ofthe electrodes based on what is seen on the fluoroscopy image.

FIGS. 24A-B and 25A-B are indicative of potential radiopaque directionalmarker bands that could be designed into a leadwire containingdirectional electrodes. The two designs work in essentially the samemanner. When a leadwire with directional electrodes is implanted in apatient, a physician can take, e.g., a fluoroscopy image of the patient.Depending on the image the physician sees in the fluoroscopy image, thephysician can tell in which direction the electrodes are pointing due tothe asymmetry of the marker band. This helps when programming thepatient.

For example, in FIGS. 24A and 24B, the leadwire may include two windows2400 and 2402, each extending 180°, one on top of the other. The windowsmay be shifted relative to each other by a number of degrees, e.g., 30°,45°, or 90°. In an example embodiment, they may be advantageously offsetby 90° as shown in FIGS. 24A and 24B. Similarly, in FIGS. 25A and 25B,the leadwire may include two triangular shapes 2500 and 2502, eachextending 180°, one on top of the other. The shapes may be shiftedrelative to each other by a number of degrees, e.g., 30°, 45°, or 90°.In an example embodiment, they may be advantageously offset by 90° asshown in FIGS. 25A and 25B. Other shapes may be similarly used.

FIG. 26 shows an image set that can be displayed in the interface screenaccording to an example embodiment of the present invention. Forexample, views for 0° 2600, 45° 2602, 90° 2604, 135° 2606, 180° 2608,225° 2610, 270° 2612, and 315° 2614 may be displayed. In other exampleembodiments, differences in the rotational position of the leadwire inthe displayed views may be by a different number of degrees. As shown inFIG. 26, depending on the rotational position of the leadwire, the twomarkers would be seen at different locations, and in some positions, oneor both of the markers would not be seen at all (though a shadow may beseen as shown, e.g., at 2602-2610, depending on the imaging modality).The physician would select, via the user interface, which pictures mostclosely relate to the image the physician is viewing in a fluoromachine, CT, or MRI. The physician may also select the direction inwhich the fluoro image was taken (AP, Lateral, or oblique angle). Theprogramming software would then automatically locate the leadwirerotationally in the 3-D viewer allowing for more knowledge of theleadwire directionally in the patient's anatomy and thus easierprogramming of the patient.

In an example embodiment, the system and method provides for the user tomatch the image obtained via fluoroscopy to an image displayed on theuser interface screen (these could be displayed in any number ofincrements, e.g., every 45° as shown in FIG. 26). This would allow thesoftware to properly align the lead rotationally in the 3-D display.

Example Model Output

FIGS. 3 a-3 j illustrate generally examples of output of the clinicianprogrammer system according to example embodiments of the presentinvention. FIG. 3 a illustrates generally an example of output includinga 3-D view of one or more substructures of a patient's brain, includinga thalamus 305 and a subthalamus nucleus (STN) 310. In the example ofFIG. 3 a, an electrode leadwire 315 is shown in the thalamus 305. Incertain examples, the electrode leadwire 315 can include amicroelectrode configured to record electrical information indicative ofa location of the brain. In addition or alternatively, the electrodeleadwire 315 can include one or more stimulation electrodes.

In an example embodiment of the present invention, the system isconfigured to display one or more coronal, sagittal, or axial slices ofthe patient's brain, or of a representation of the patient's brain(e.g., a model, a stretched or deformed brain atlas, or otherrepresentation). In other examples, other structures or substructures ofthe patient's brain can be shown or represented using the clinicianprogrammer system.

FIGS. 3 b-3 c illustrate generally an example of clinician programmersystem output including a 3-D view of one or more substructures of apatient's brain, including a thalamus 305 and a STN 310. In the exampleof FIG. 3 b, an electrode leadwire 315 may be used to determine one ormore locations of one or more substructure. For example, when theelectrode leadwire 315 (or at least one contact on the electrodeleadwire 315) is in the thalamus 305, the electrode leadwire 315 canreceive information indicative of the thalamus 305. As the electrodeleadwire 315 is progressed into the brain, information can be received,e.g., at one or more specific or random intervals. In the example ofFIG. 3 b, information can be received at different locations, e.g.,location 320-329, etc. The information received at location 320 isindicative of the thalamus 305, and is accordingly marked as such (e.g.,visually, with a yellow color). Using this information, one or moremodel, atlas, or other representation can be stretched, deformed, orotherwise altered according to the information.

In certain examples, more than one electrode leadwire can be used, orthe electrode leadwire 315 can be inserted in more than one location toreceive information indicative of the location of a patient's structureor substructure.

FIG. 3 c illustrates generally an example of clinician programmer systemoutput including a 3-D view of one or more substructures of a patient'sbrain, including a thalamus 305 and a STN 310, similar to that shown inFIG. 3 b, although shown in relation to the overall structure of thepatient's brain.

Intra- and Post-Operative Steps

FIG. 7 illustrates generally an example of a method 700 includingimporting, e.g., post-surgical patient MR and CT scans, comparingpost-surgical scans to a surgical plan, reviewing intra-operativestimulation results, selecting programming parameters, reviewingstimulation field models, and adjusting parameters to optional fieldorientation.

At 705, post-surgical patient MR and CT scans or one or more othermedical images are imported.

At 710, post-surgical scans are compared to the surgical plan. In anexample, the post-surgical scans are compared to the surgical plan toverify correct placement, direction, or location of the leadwire orother component. For example, if there is a difference, the leadwire maybe moved.

Returning to FIG. 6, at step 620, a stimulation is applied and thelocation of the electrodes relative to the brain structures is confirmedaxially and rotationally, e.g., based on one or more medical images orother sensor or observed data.

For example, referring again to FIG. 7, the confirmation may include areview, at step 715, of intra-operative stimulation results. That is,trial stimulations may be performed prior to closing of the patient'shead to determine whether any benefits and/or side effects result fromthe stimulations with the leadwire at its present location. For example,depending on the results, the leadwire may be left in its presentlocation, the leadwire may be removed, or the leadwire's location may bechanged.

Referring again to FIG. 6, at step 625, results from stimulation andoptimal electrode settings are recorded and/or stored, e.g., using theclinician programmer system.

For example, returning to FIG. 7, after the patient's head is closed,program parameters may be selected at step 720. In an example, theprogram parameters or other therapy parameters are selected by theclinician or other user. In an example, the clinician programmer systemcan suggest optimal program parameters, e.g., parameters that arepredicted to result in an estimated VOA that closely corresponds to atarget VOA manually input as described above or automaticallydetermined, for example, based on a therapeutic goal.

In an example embodiment, the clinician programmer system, using a 3-Dmodel, atlas, or other representation of a patient's brain, can estimatea VOA as described in detail below and display the estimated VOA on the3-D model or other representation.

FIG. 3 d illustrates generally an example of clinician programmer systemoutput including a 3-D view of one or more substructures of a patient'sbrain, a stimulation leadwire 335, and a VOA 340. In an exampleembodiment of the present invention, the stimulation leadwire 335includes one or more electrical contacts or electrodes (e.g., electrode336, etc.), configured to selectively deliver a stimulation energy to atleast a portion of the brain.

At 725, the VOA estimated for the selected program parameters isreviewed.

At 730, based on the review, stimulation parameters are adjusted tooptimal stimulation field orientation. In an example, the parameters canbe adjusted to account for variation between the surgical plan and theactual leadwire or other component placement, direction, or location.

In example embodiments of the present invention, results of stimulationscan be uploaded, stored, or otherwise used to create or update adatabase of computed therapy parameters, e.g., to determine predictivealgorithms or other relationships between different varying therapyparameters as described in more detail below.

Parameter and VOA Configuration

In an example embodiment of the present invention, the clinicianprogrammer system is configured to calculate, define, establish, orotherwise set or alter one or more therapy parameters using the createdpatient-specific brain atlas or other model or representation of thepatient's brain including the implanted lead location.

In an example embodiment of the present invention, once the rendition ofthe stimulation electrode leadwire implanted in the patient's brain andthe rendition of the local anatomic structure have been created, e.g.,once a model of the patient's brain had been created, adjusted, orotherwise established, programming of the energy delivery can begin. Incertain examples, the desired stimulation parameters (e.g., stimulationpulse amplitude, pulse width, frequency, etc.) can be entered into theclinician programmer system. The amplitude can range, e.g., between 0-20mA. Pulse width can range, e.g., between 10-1000 second per phase, andfrequency can range, e.g., between 1-1200 Hz. Other ranges may also beused. In an example embodiment, once the stimulation parameters havebeen entered, the clinician programmer system is configured to predict aVOA. In an example embodiment of the present invention, the clinicianprogrammer system is configured to graphically show the VOA with respectto the implanted stimulation electrode leadwire and the patient's brain.In an example embodiment of the present invention, the system isconfigured to predict one or more potential side effects based on thepredicted VOA interacting with adjacent anatomical structures. Thesystem is configured to display these side effects to a user, such asgraphically or textually using the viewer/navigator or other display.

In an example embodiment of the present invention, once a model of thepatient's brain has been created, adjusted, or otherwise established,the system is configured to receive input of a desired VOA (e.g., adesired VOA created, drawn, or otherwise input by a user). For example,the clinician programmer system may display a 3-D rendering of ananatomical substructure of the patient's brain and allow a clinician orother user to input, e.g., graphically, a desired ESF or VOA. Forexample, the clinician programmer system may include a user-interface,such as a mouse, a stylus, or other input device, and may be configuredto receive information from the user-interface to create the desired ortarget VOA.

Alternatively, the system may automatically determine a suggested VOAusing information about the patient. For example, the clinician or otheruser can input a desired therapy outcome, or other information, such aspatient condition, indications, symptoms, or other information for useby the system to determine the VOA.

In an example, selection of the VOA may be based on analysis of priorVOAs with regard to anatomical location and comparison to outcomeresults (progressively on the software, off-line on another computer,etc.) or through anatomical landmarking where a target volume isdetermined by the expected anatomical and physiological response. Forexample, based on benefits and/or side effects resulting from previousstimulations using parameters corresponding to certain estimated VOAs, atarget region for stimulation may be formed, e.g., for a specific singletherapy or for a total patient benefit for a desired combination oftherapies.

In an alternative example embodiment, selection of the VOA may beperformed without reference to anatomical structures. Instead, priorVOAs may be analyzed solely with respect to the leadwire and based onpatient clinical data to determine benefits and side effects associatedwith those VOAs as defined relative to the leadwire. Accordingly, a VOAmay be selected relative to the leadwire, without regard to theparticular anatomical structures with which it overlaps.

In an example, once the desired or target VOA has been input, received,or created (automatically or via user input), it can be displayed to theclinician or other user using the clinician programmer or other displaydevice, e.g., in order to validate the created desired or target VOA.

In certain examples, the desired VOA is created in 2-dimensions (2-D) onone or more slice or other 2-D representation of the patient's brain orsubstructures of the patient's brain (e.g. a plane orthogonal to thelead), or the desired VOA is created in 3-D on a representation (3-D orother) of the patient's brain or substructures of the patient's brain.

In an example embodiment of the present invention, once the desired VOAhas been received, created, or validated, the system is configured todetermine (e.g., using an algorithm and based on a given leadwirelocation relative to the desired VOA and relative to various anatomicalstructures) optimal programming parameters to obtain a VOA as close aspossible to the desired VOA (e.g., with minimal side effects). Forexample, the system may analyze different therapy parameters, such aselectrode or leadwire location, configuration, shape, etc., orstimulation settings or parameters, in order to produce the desired ortarget VOA. In an example, the clinician programmer system is configuredto compute optimal therapy parameters using the 3-D rendering, and isconfigured to display the calculated optimal electrode configuration orthe calculated optimal resulting VOA from the calculated optimal therapyparameters using a display device. In an example, the calculated optimalVOA can be compared to the desired or target VOA.

In an example embodiment, for a desired or target VOA, the clinicianprogrammer system is configured to display, for selection by a clinicianor other user, one or more calculated therapy parameter optionscorresponding to respective VOAs determined to be close to the targetVOA. In this regard, it is noted that the exact target VOA may not beobtainable. In an example, the desired or target VOA can be comparedagainst the VOA computed for a particular parameter set. For example,for a suggested parameter set, the system may display the estimated VOAcorresponding to the parameter set overlaid on the target VOA.

Alternatively, the system may be configured to automatically set thedetermined optimal parameters.

In an example embodiment, the clinician programmer system is configuredto compute a score for a VOA computed for a parameter set in relation tothe desired or target VOA. In certain examples, the scoring can be basedon the amount of the desired or target VOA encompassed by the computedVOA, the amount that the computed VOA exceeds the desired or target VOA,the predicted or past side effects or efficacy of at least a portion ofthe computed VOA in the patient or other patients, etc., or acombination of one or more of the scoring options shown above or otherscoring options.

In an example embodiment of the present invention, a secondaryprediction of outcome, such as positron emission tomography (PET) scan,can be used to determine optimal therapy parameters. In an example,these secondary predictions can be performed following or in conjunctionwith test stimulations, entered into a database in relation to therespective therapy parameters, and be included as part of the scoringfactor for possible VOA calculations.

Prediction Algorithms

In an example embodiment, the system is configured to compute a scorefor one or more possible VOAs (e.g., a score can be computed for everypossible VOA, such as by computing a score for each possible variationin each therapy parameter) in relation to the desired or target VOA.However, computing a VOA for each variation in each therapy parametercan take a large amount of time and processing power. In order toalleviate these and other issues, embodiments of the present inventionprovide a predictive algorithm for computing optimal parameters for adesired or target VOA.

In an example embodiment of the present invention, the clinicianprogrammer system is configured to compute an estimated VOA for eachvariation of separate therapy parameters (e.g., for each stimulationparameter variation; such as a range of stimulation amplitude,frequency, pulse-width, duty cycle, etc.; a change in leadwire locationor electrode configuration; and/or other therapy parameter).

In an example embodiment, one or more computed and/or actual VOAs fromthe patient or other patients are recorded or stored, e.g., in relationto leadwire placement, electrode location, and/or parameter settings, asa library of computed and/or actual VOAs. Thus, once a leadwire has beenimplanted, the possible VOA at that leadwire location, electrodeselection, and/or parameter setting(s) can be predicted or shown usingthe library of recorded or stored computed VOAs from the same or similarleadwire location, electrode selection, and/or parameter setting(s). Assuch, a VOA can be predicted using the therapy parameters from thepreviously computed or actual VOAs.

For example, using the library of computed VOA, a look-up table iscreated. This look-up table may be used to pull-up a VOA based on userselected therapy parameters. Also, the look-up table may be used todetermine therapy parameters. Further, the library of computed VOA maybe used to develop one or more general relationships for estimating arange of VOAs using one or more computed VOAs.

For example, for a given set of therapy parameters, a set of computedVOAs can be created for the complete range of varying pulse width (e.g.,100 computations, from a duration of 1% of the period, each computationincreasing by 1% to a duration of 100% of the period). In an example, arelationship can be developed illustrating the effect to the computedVOA for each variance. In an example, the relationship can be developedusing information from one or more patients, models, etc. In an example,the developed relationship can be used as a predictive algorithm. Thus,a database can be computed using one or more relationships or predictivealgorithms to determine an optimal set of therapy parameters for adesired or target VOA.

In an example, a predictive algorithm can be created for varying therapyparameters, such as electrode or leadwire location, configuration,shape, etc., or stimulation settings or parameters. For example, anequation relating various parameters to predicted VOAs may be generatedas described in more detail below.

In an example embodiment of the present invention, the database ofdeveloped relationships or predictive algorithms are updated with everyactual computation, and can be used in order to compute optimal therapyparameters for a desired or target VOA without separately computingevery varying possible VOA.

In an example, for a given target VOA (e.g., input by a user), a smallnumber of actual computations (e.g., one, two, or more computed VOAusing varying test therapy parameters) can be performed, and, using thedatabase of predictive algorithms, be correlated or best fit to previouscomputations to find the estimated optimal therapy parameters.

VOA Estimation and Equation Generation for Monopolar VOA Estimation

In an example embodiment of the present invention, the system maycalculate a VOA for a monopolar electrode configuration, where thecurrent source is from one or more contacts on the DBS leadwire and theground is at a casing of an IPG located some distance from the DBSleadwire. In an example embodiment, for the calculation of the VOA for amonopolar electrode, the system and method may model an area of apatient, e.g., an area of the brain of the patient; model voltages atvarious points within the patient model; model axons within the patientmodel; model a waveform for a given set of DBS parameters; determine thevoltage at various points along the model axons due to the axon'slocation relative to the electrodes; determine for the modeled waveformthe injected current amplitude required for axon activation at therespective axons' modeled voltages; determine which axons of the modelwill be activated based on whether the amplitude meets the requiredthresholds of the respective axons; and generate a representation of anarea formed by the axons that the system and method determined will beactivated. In this regard, in an example embodiment of the presentinvention, the threshold current amplitude value required at an axon iscalculated based on a second order derivative of the voltage, so that arate of change at a point in space determines whether a neuron isactivated. In other example embodiments, other methods may be used todetermine the required threshold current amplitude values.

In an example embodiment of the present invention, for the calculationof the VOA for a monopolar electrode, the system and method mayinitially calculate a plurality of VOAs for various sets of DBSparameters as in the previous paragraph. Based on the data obtained fromthe generation of the VOAs for the sets of DBS parameters, the systemand method may determine a function whose input are the DBS parametersand whose output is the necessary voltage values required for firing ofan axon at the input DBS parameters. Subsequently, the system and methodmay, for a further set of DBS parameters, model the voltages and axonsin the patient model and determine the isosurface, i.e., the boundarysurface of axons predicted to be activated, and, thus, the VOA, based onthe determined function.

FIG. 13 is a flowchart that illustrates an example method forcalculation of a VOA for a monopolar electrode (left side of FIG. 13).At step 1302, a Finite Element Analysis (FEA) program, e.g., Comsol, maybe used to create a 3-D model of the stimulation electrode leadwire, anencapsulation layer that defines an area in which scar tissue generallyforms after insertion of the electrode leadwire, tissue, and the IPG. Atstep 1303, the FEA program may be used to solve a voltage field for thegiven electrode contact combination. In this regard, a number ofelectrode contact combinations may be implemented independently, and foreach combination, the FEA program may solve a respective voltage field.For example, a different number of electrode contacts may be activatedin different setups.

The FEA program may set up a large series of differential equationsdefining the voltage in the region surrounding the electrode. The setupmay assume a 500 μm encapsulation layer surrounding the electrode. Theconductivity of this layer is changed to simulate brain tissue withhigher or lower impedance. In this regard, the impedance of theencapsulation layer is different from patient to patient and session tosession because it is based on the immune reaction of the body. Theencapsulation layer is a result of the body's natural tendency to formscarring around the foreign body (the lead in this case) and differsfrom person to person. Based on clinical studies, the impedance of thislayer has been determined to vary such that it is, in an exampleembodiment of the present invention, variably modeled as low, medium,and high. The system impedance can be read in real-time and the modelused to determine the voltages can be adjusted accordingly. In analternative example embodiment, calculations are obtained forconductivity related to all three impedance values, i.e., low, medium,and high.

At step 1304, one of the electrode contact combinations is selected asrepresentative of the leadwire geometry. An example leadwire geometrymay that of a leadwire that has: a length of 10-50 cm; a straight shape;a body diameter of 1.27 mm; an in-line connector; and four electrodes ofcylindrical shape that are each 1.5 mm in length and that are spacedfrom each other by 0.5-1.5 mm. That is, although voltage fields for anumber of electrode contact combinations may be initially determined foran electrode geometry, in an example embodiment of the presentinvention, only one voltage field is fed to a neuron simulation programfor an initial threshold determination as described below. Subsequently,an equation may be used for finding the thresholds for the other voltagefields of other electrode contact combinations of the electrodegeometry, as described below.

The voltage field calculated for the selected electrode contactcombination may be provided to a matrix solver, e.g., Matlab. At step1305, the matrix solver may create an axon model, indicating pointsalong its length which correspond to myelin, nodes of Ranvier, etc. Atstep 1306, the matrix solver may create a cylindrical array of points.At step 1307, the matrix solver may, for each point of the array ofpoints, place an instance of the modeled axon with its center at thepoint of the array. The resulting array of axons may be placedtangentially and horizontally to the modeled lead. At step 1308, thematrix solver may save in a .dat format the voltage values of the FEAobtained for the selected electrode contact combination at the pointsalong the axons arranged about the lead.

At step 1309, the matrix solver may create a waveform for a pulse of theDBS electrode. The waveform may have features including a wave-shape(e.g., square, sine, or triangle) and a pulse width. For example, thevarious pulse width values may be selected at predefined increments. Thewaveform may be dependent on currently set parameters. The waveform mayvary depending on the specific IPG used. Exemplary wave shapes which canbe applied include triangle, sine, square, Gaussian, etc., differentones resulting in different VOAs. In an example embodiment, the overallshape may be first selected, and then the shape can be modified tochange the pulse width, amplitude, etc. Difference equations may bedetermined for difference wave-shapes. For each wave-shape, the pulsewidth may be varied for the various waveforms.

At step 1310, a program that simulates neurons, including ion channels,membrane properties, and other relevant properties to depict neuralresponses, e.g., Neuron, a non-proprietary program developed by DukeUniversity and Yale University, determines an activation threshold ofeach of the modeled axons and associated voltages of the .dat file basedon the waveform created by the matrix solver. For example, the systemand method may determine a required amplitude for activation of an axongiven the voltage values determined along its length, by varying thewaveform amplitude to determine the threshold at which each axon fires.

In an example embodiment of the present invention, the threshold valuesfor a given set of electrode parameters may be compared to the voltagevalues at the locations of the modeled axons in the generated anatomicalpatient map to determine the cutoff boundary for axon activation. Thesystem and method may visually indicate in a displayed anatomical mapthe region including the axons that will fire given the inputparameters. That is, the determinations may be applied to a structuredgrid surrounding the lead, so that they are arranged relative to thelead, and the grid may be applied to the patient map.

In an example embodiment of the present invention, the system andmethod, e.g., via Matlab, may plot the threshold values determined bythe neuron simulator at the centers of the modeled axons. At step 1311,the system and method may again take the voltage values at these samepoints in space at the center of the axons. For determining an equation,the system and method may use the current amplitude threshold valuesobtained in repeated performance of the above described steps, thedifferent instances of their performance using different pulse widthwaveforms to simulate stimulation of the neurons, the reactions to thedifferent pulse widths being recorded. Thus, different threshold valuesmay be determined for different waveforms. At step 1312, a curve fittingprogram, e.g., Excel, may compare the plotted threshold values recordedfor the various simulated waveforms to the voltage values at the plottedlocations in the modeled axons and determine an equation which relatesthe two. In this regard, the voltages may be used as representative ofhow the field falls off relative to the source. For example, an equationof Volt=(C₁ ²*PW+C₃)*Amp^((C) ⁴ ² ^(*PW+C) ⁵ ^(*PW+C) ⁶ ⁾ may bedetermined, where Volt corresponds to the voltage threshold, Ampcorresponds to the desired current or voltage amplitude being sentthrough the electrode, PW is the pulse width of the waveform, and C₁₋₆are coefficients to fit the given leadwire type and/or wave-shape. Thus,between various determined equations, the coefficients C₁₋₆ may vary.The above-described process is repeated at least three times, each timewith a different impedance level. The coefficient values vary dependingon impedance. The variables determined for the curve fitting performedfor each of the impedance levels are then further fit to produce anoverall function with voltage values on one side and amplitude, pulsewidth, and impedance on the other side.

Subsequently, for various electrode settings of amplitude, pulse width,and impedance, the voltage at which an axon fires may be determineddirectly from the determined function. At step 1313, the system andmethod, e.g., via Matlab, may record the voltage readings at specificpoints from FEA and save values in a new format. The clinicianprogrammer system may, at step 1314, apply the calculated function ofvoltage vs. amplitude/pulse width/impedance to the voltage values of the.vtk file to obtain an isosurface of the cutoff boundary for axonactivation, the area within the boundary being an activated region.Accordingly, while only a single representative electrode contactcombination was selected for determining the threshold values, thethreshold values for the other combinations (of the same electrodegeometry) may be determined based on the calculated function.

VOA Estimation and Equation Generation for Bipolar VOA Estimation

In an example embodiment of the preset invention, the system maycalculate a VOA for a biopolar electrode configuration, where thecurrent source is from one or more contacts on the DBS leadwire andground is at another one or more contacts of the DBS leadwire. In anexample embodiment, for the calculation of the VOA for a bipolarelectrode, the system and method may initially calculate a plurality ofVOAs for various sets of DBS parameters for a monopolar electrode.However, instead of pairing wave amplitude thresholds against voltages,as described above, the system and method may obtain an electric fieldbased on the gradient of the modeled voltage field, multiply theelectric field by a scalar, representing tissue conductivity, to obtaina current density field, multiply the current density field by a scalar,representing pulse width, to obtain a charge density field, and thenpair the amplitude thresholds against the charge density values. Afunction may then be obtained as described above, except that thefunction's output is the necessary charge density value required forfiring of an axon at the input DBS parameters. The system and method maythen, in the bipolar case, scale down or remove anodic values and obtaina charge density field as in the monopolar case. The system and methodmay determine for each modeled axon whether it will fire by input of thecorresponding charge density values into the determined function,thereby obtaining an isosurface and VOA.

FIG. 13 also illustrates an example method for calculation of an SFM fora bipolar electrode (right side of FIG. 13). The process may begin withperforming a modified version of steps 1302-1313 for a representativemonopolar geometry and electrode contact combination.

The modified version may include, steps 1311 a-1311 d and 1312′. At step1311 a, the system and method, e.g., via Matlab, may determine anelectric field based on the determined voltage field. At step 1311 b,the system and method, e.g., via Matlab, may multiply the electric fieldvalues by a scalar (e.g., representative of tissue conductivity) toobtain a current density field. At step 1311 c, the system and method,e.g., via Matlab, may multiply the current density field by a scalar(e.g., representative of the pulse width of the presently consideredwaveform) to obtain a charge density field. At step 1311 d, the systemand method, e.g., via Matlab, may map the charge density values atpoints in the cylindrical array of points of step 1306.

At step 1312′, a curve fitting function may be used as described aboveto obtain an equation. This equation may differ from the equationdescribed above with respect to 1312 in the monopolar case, in that thisequation may solve for charge density values rather than voltage values.(It is noted that this equation may also be usable for solving for a VOAin the case of a monopolar electrode configuration.) At step 1313, thesystem and method, e.g., via Matlab, may record voltage readings atspecific points in 3-D space from FEA and save the values, e.g., in anew format.

After a voltage field is obtained for the bipolar geometry, e.g., asdescribed with respect to the monopolar geometry (this step is notshown), the system and method, e.g., via Matlab, may, at step 1315,threshold the voltage values obtained for the bipolar geometry to scaledown or remove anodic data. At step 1316, the system and method, e.g.,via Matlab, may solve for a corresponding electric field by taking thespatial gradient. At steps 1317-1318, the clinician programmer systemmay obtain charge densities as described above with respect to steps1311 b-1311 c. At step, 1314, the clinician programmer system may usethe charge density function to obtain a charge density threshold value(also referred to as an isosurfacing value) and apply the thresholdvalue to the charge density values of the bipolar geometry, therebycreating an isosurface at the threshold level. In this instance, thestep 1314 may be applied to the charge density field rather than thevoltage field.

Thus, VOAs are created in distinct ways for the monopolar and bipolarcases in example embodiments of the present invention. The monopolarmethod provides for estimating the results from an array of modelneurons in a voltage field. Due to the large voltage gradient, thismethod may be difficult to implement in the bipolar case. Instead, inthe bipolar method, the voltage data is transformed into a chargedensity vector field and then has a threshold set.

Details Regarding the Monopolar and/or Bipolar Configurations

In either case, creating VOAs may start in Comsol or another FEAprogram. First, a three dimensional model is created, including theleadwire, an encapsulation layer surrounding the lead, brain tissue, andthe IPG. The conductivity of the encapsulation layer is changed tosimulate brain tissue with higher or lower impedance and the combinationof contacts which are to be active is chosen. The differential equationsinferred by these geometric properties yields a description of thevoltage field emitted into the simulated brain tissue. This FEA voltagefield is output from the program and used several times later on.

The next step in a monopolar scenario is to set up an arrangement ofmodel axons. Their location is defined, for example, in Matlab. First,the spatial separation of important locations (e.g., the nodes ofRanvier, myelin sheath, etc.) is defined for a single axon. Second, acylindrical array of points is spatially defined. Then, these two arecombined so that the points in space are set as the center of each axon,which are then aligned horizontally and tangentially to the lead. FIG.14 shows an example model axon 1400, cylindrical array of points inspace 1402, and application of the model axon to the array 1404. Thisgives a set of points in space at which the voltage values are relevant.The system and method, e.g., via Matlab, then obtains these values andsaves them as a .dat file. In addition to this, Matlab may be used tocreate a waveform for the run with a given wave shape and pulse width.

Next, Neuron, for example, takes into account the waveform and the .datfile and determines the stimulation amplitude at which each axon willfire. Each of these thresholds is plotted at the center of the axon,thus giving a value to each of the points on the cylindrical array.However, since a single run can take more than six hours, in an exampleembodiment, this is not done for every possible combination ofelectrodes, sources, etc. Instead, the original voltage field isisosurfaced at a level determined by a single selected representativeelectrode contact combination.

In order to generate the equation relating the voltage fields to theNeuron thresholds, voltage values need to be taken which correspondspatially to the thresholds. Matlab, for example, is again used, thistime to find voltage values at the points defined by the abovecylindrical array. Each of these data points is paired with thethreshold data from the same point in space. Curve fitting in Excel canbe used to obtain an overall equation to relate these pairs. Thisprocess is repeated for a range of pulse widths (changed in thewaveform) and tissue impedances (changed in Comsol).

The clinician programmer system will read this data from a library ofthese voltage fields. Each combination is obtained by having voltageread at given points in space from the FEA and the resulting set of datasaved in a .vtk file. The clinician programmer system then inputs theimpedance, pulse width, and current amplitude into the equation and usesthe resultant voltage value to isosurface the chosen voltage field andproduce a VOA. All of the area within this isosurface is thus said to beactivated as the VOA.

FIG. 15 illustrates the two passes for generating VOAs. In a first pass1500, Neuron, for example, is used to directly obtain threshold valuesfor a selected representative electrode contact combination, which isthen used to obtain a function which is used in subsequent passes 1502to obtain the VOAs for other amplitude, pulse width, and impedancesettings. Further, the same equation can be used for voltage fields ofvarious electrode contact combinations using the same leadwire.

In the bipolar case, the next step is to obtain the voltage values atthe points along the same cylindrical array using, e.g., Matlab. Thismust be done with a selected representative monopolar electrode contactcombination in order to get another equation. A script is run whichcalculates the second spatial derivative, which gives the gradient ofthis field, producing the electric field. The electric field is thenmultiplied by the tissue conductivity to obtain the current density andthen the pulse width to get the charge density. The charge densityvalues are then recorded at the same spatial points and again, Excel,for example, is used to compare them to the activation thresholdsobtained from, e.g., Neuron in the previous step of the monopolar case.This results in an equation which takes as input the amplitude, pulsewidth and impedance and gives the correct current density value.

Once this equation has been identified, a library of current densityfields may be created for various additional electrode contactcombinations. For each of the additional electrode combinations, thevoltage field is again saved from the FEA and the gradient obtained inMatlab. This is multiplied by the conductivity, which is the same inevery case, and these current densities are saved. The clinicianprogrammer system then opens the correct library entry, multiplies it bythe desired pulse width and uses the equation to determine theisosurface value and create the VOA.

FIG. 16 illustrates the described method for generating VOAs in thebipolar case, which method includes a first pass 1600 using Neuron toobtain thresholds for a representative monopolar case and subsequentpasses 1602 using an equation to obtain the thresholds for the bipolarcase.

Highlighting of Overlapping Areas between VOA and Structures

The right window, partition, or frame of FIGS. 3 e-3 f illustratesgenerally an example of a display which may include a two or threedimensional rendering. In an example, this window, partition, or framecan be configured to display a number of different images (e.g., aComputer Tomography (CT) Scan; a Magnetic Resonance Imaging (MRI); or aDiffusion Tensor Imaging (DTI)); a two or three dimensional anatomicalatlas, such as the Schaltenbrand-Wahren Atlas, the Morel Atlas, etc.; atwo or three dimensional representation of an implantable lead; and/or atwo or three dimensional image of the VOA, etc.).

In certain examples, an anatomical structure or substructure is labeledwith the name of the structure, benefits of stimulating the structure,and/or side effects of stimulating the structure. For example, thesystem may include a database of information regarding variousanatomical structures and their associated benefit and/or side effect.The system may determine with which of those structures a VOA interactsand label or otherwise identify the structures according to theirassociated benefits and/or side effects as determined by access to thedatabase. In an example embodiment, the database may be updated based onuser-entered information, e.g., side effect scores entered in a notesfeature (discussed in further detail below) in association withparticular leadwire settings as shown in FIG. 3 h.

In an example embodiment of the present invention, the system isconfigured to highlight where the VOA overlaps with different anatomicalstructures or substructures. In example embodiments, the system isconfigured to highlight or otherwise illustrate the differentinteractions by different colorings, different shading, hatchingpatterns, or with other identifying techniques.

In an example embodiment of the present invention, the system isconfigured to identify overlapping beneficial and/or adverse regions ina similar manner. For example, the system may store informationregarding one or more benefits or side effects with respect tostructures in an atlas or map, such that when those structures arestimulated, the stimulation may cause certain therapeutic benefitsand/or side effects. This benefit/side effect atlas or map can be storedand shown in two or three dimensions. In certain examples, differentbenefits or side effects can be identified by a display using differentcolor coded structures or substructures, different intensity patterns,different hatching patterns, via text on screen, etc., as shown in FIGS.3 e-3 f, in which overlapping areas between a VOA and an anatomicalstructure or substructure are highlighted in different ways.Specifically, in FIG. 3 e, for example, yellow is used to show a sideeffect region 3003 and dark red is used to show a benefit region.

Such information can be used by the clinician to determine whether aninput or otherwise selected parameter set is optimal.

In an example embodiment, the modeling area perspective can be rotated,changed, zoomed, or otherwise altered using one or more inputs orselectors. In an example, the overall perspective of the view in themodeling area can be related back to the patient orientation model 3030shown as a model of a patient head at the bottom right corner of FIG. 3e. In an example, the patient head or other similar input may besimilarly used with respect to the various screenshots shown in FIGS. 3a-3 j. In certain examples, the patient orientation model 3030 can berotated by clicking and dragging, or the patient orientation model 3030can solely reflect the changes made to the modeling view using otherinput mechanisms.

In an example embodiment, the system may provide for display of themodel, VOA, and structure overlap in a 3-D view and/or in a 2-D view.For example, the particular views may be user-selectable. For example,the VOA may be displayed in a same cross-sectional view of, andoverlaying, an MRI cross-section, as shown in FIG. 3 f. Moreover, themodel atlas structures may be similarly displayed in either a 3-D viewor in a 2-D cross-sectional view of, and overlaying, an MRIcross-section and VOA. All such views may further include the overlaphighlighting.

In an example embodiment, the system may provide a user interface forreceiving user input to scroll between cross-sectional MRI andcorresponding VOA and atlas structure views. For example, the patientorientation model 3030 may include a selectable slice bar 3031 which maybe dragged axially and/or rotationally, in response to which the systemmay display a view corresponding to the section of the patientorientation model 3030 to which the slice bar 3031 has been dragged.Alternatively, a different user input may be provided for changing thecross-sectional view. According to this embodiment, the slice bar 3031may be omitted or may be displayed to provide the user a visual contextof the view being displayed.

In an example embodiment of the present invention, the system may beconfigured to additionally display sagittal, coronal, and axial views.

Notes Feature

In example embodiments of the present invention, a system and method mayprovide a notes feature which may be used as an aid for selecting anelectrode parameter combination. Notes may be entered, which may includeinformation regarding settings, benefits, and/or side effects of astimulation, and/or other observations or information regarding astimulation and/or patient.

While a VOA is displayed, a user may input data responsive to which thesystem creates a new note. The system may display an icon representativeof the note in a location that visually indicates and corresponds to aVOA to which the note corresponds. The note may be displayed at thelocation even after the VOA is removed from display and even while adifferent VOA is displayed. Many notes, for example where each isassociated with a different VOA, may be simultaneously displayed so thata user can quickly associate the various notes with their respectiveVOAs. In an example embodiment, the system may alternatively oradditionally automatically generate a note, e.g., where a side effectand/or benefit associated with a stimulation is detected.

FIG. 3 g is a screenshot according to an example embodiment of thepresent invention. The screenshot includes a right portion or frame inwhich a generated VOA is displayed in an anatomical patient map, suchthat the VOA is shown to overlap certain anatomical features. Thescreenshot includes an “Add Note” button 3040. A user may select thebutton 3040, for example, by operating an input device, such as a mouseto move a graphical pointer to a location overlying the button 3040, andby pressing a mechanical button, e.g., of the mouse, while the pointeris displayed in that position, or a touch screen. In response, auser-interactive note entry form 3050 may be displayed, e.g., as shownin FIG. 3 h, via which a user may enter the substance, e.g., text, ofthe note. Upon saving of the note, the system and method mayautomatically append an icon 3045 representative of the note to the VOAmap at a location corresponding to the VOA for which the note wascreated (the VOA displayed when the note was added). For example, asystem and method may display the note icon 3045 at a location in theanatomical map which coincides with a point on the outer boundary of theVOA. In an example embodiment of the present invention, a plurality ofnotes may be input for a single VOA.

Over time, a plurality of notes may be appended for a plurality of VOAs.In a selected view, although only one VOA is displayed, e.g., the latestgenerated VOA, icons 3045 representative of notes associated with all ofthe previously generated VOAs (or a selected subset of the previouslygenerated VOAs) may be simultaneously displayed, each icon at a locationthat coincides with a point on the outer boundary of the note'scorresponding VOA, e.g., as shown in FIGS. 3 h and 3 i. A system andmethod may accordingly visually indicate the VOAs with which the variousnotes are associated. Further, note icons 3045 may be displayed indifferent colors to indicate whether the VOA to which the note iconcorresponds is associated with a side effect or a benefit. For example,certain ones of the note icons 3045 in FIG. 3 g are yellow to indicatethat the respective note icon corresponds to a VOA associated with aside effect. Alternatively, other visual differences between the noteicons, such as with respect to hatching, shading, transparency, shapes,etc., may be used.

Further, the note icons may be selectable, in response to whichselection, the system and method may display the associated note. Theuser may accordingly, quickly view notes and visualize the VOAs withwhich they are associated, to obtain a quick VOA history. The VOAhistory may include VOAs of implemented electrode contact combinationsand lead parameters and/or projected VOAs of test combinations andparameters which have not yet been implemented.

Flashlight Feature 2-D and 3-D

In an example embodiment of the present invention, a system includes atwo or three dimensional flashlight feature. In an example, a system isconfigured to display to a user, in a 2-D or a 3-D visualization, one ormore areas of an atlas or other patient model or map (e.g., one or moreareas of the MRI and/or CT images or other medical images) that havebeen stimulated by the VOA and/or for which stimulation has beensimulated, for example, an explored region 3060 as shown in FIG. 3 i.The display may be of a three-dimensional volume or a two-dimensionalslice. Further, the system may provide for selection of predefinedviews, such as axial, coronal, and/or sagittal. The system may providefor scrolling through image slices in the various views.

For example, an explored region including one or more VOAs correspondingto prior actual or simulated stimulations may be shown. In an exampleembodiment, the explored region may be presented to distinguish it fromthe unexplored region using shading, color, or one or more other visualeffects.

In an example embodiment, a number of VOAs to be represented may beselectable, e.g., the first five, the last five, those corresponding toa specific time period, and/or those corresponding to stimulationshaving one or more specified parameter values and/or ranges of suchvalues.

In an example embodiment, the explored region can represent a sessionlog, including one or more regions stimulated or simulated in a singleor specified multiple sessions of stimulation. In other examples, theexplored region can represent a patient history log, including one ormore regions stimulated or simulated over a patient's history. In otherexamples, the explored region can represent a population log, includingone or more regions stimulated for more than one patient, such as apatient population. In certain examples, the patients or stimulationsincluded in the session log, the patient history log, or the populationlog can be selected, sorted, or otherwise indexed according to one ormore of patient information (such as physiological status, diseasestate, age, sex, weight, or other patient information), stimulationinformation (such as stimulation parameter, electrode configuration,leadwire location, or other stimulation information), and/or otherinformation.

This flashlight feature can allow the user to visually see those areasthat have been stimulated (actually or via simulation) in order to aidin selection of electrode and parameter values to provide the besttherapy possible for the patient. In an example, the flashlight featurecan be configured to display relevant information, while not displayingirrelevant information, or otherwise distinguish relevant informationfrom irrelevant information (e.g., using shading, color, etc.). Forexample, a user may indicate a particular desired therapy. The systemmay accordingly identify the areas of benefit for the selected therapyand not benefits for only other therapies. Similarly, the user mayindicate certain kinds of side effects that are of concern. The systemmay accordingly identify only those side effects.

In an example embodiment of the present invention, the notes feature maybe available in a display corresponding to the flashlight feature, asshown in FIG. 3 i.

Flashlight Side Effect Feature

In an example embodiment of the present invention, the flashlightfeature includes a side effect feature or algorithm for determining oneor more parameters to quickly reduce parameter space or narrow a sideeffect profile (e.g., the given side effects for a given stimulationparameter set). That is, it gives a visual representation of stimulationon surrounding tissue.

In an example embodiment of the present invention, a system supportsdisplaying to the user, in a 2-D or 3-D visualization, the areas of theatlas and/or areas of the MRI and CT images (or other medical image)that have previously caused one or more side effects (as determined bythe user or other manual or automated process) for the patient. In anexample, the area or areas causing a side effect can be displayedvisually different from the other areas of the displayed image that arenot associated with a side effect(s). In an example, if an area does nothave an associated side effect, the “side effect” visual difference canbe removed, allowing a user to determine one or more specific areaswhose stimulation cause one or more side effects for this patient.

FIG. 3 j illustrates generally an example of displaying priorstimulation areas in two or three dimensions as well as indicating(e.g., labeled via color, texture, size, etc.) those stimulation areasthat have been associated with one or more side effects. In the exampleof FIG. 3 j, the side effect areas are displayed in yellow outside ofthe currently represented VOA. The flashlight side effect feature may beon a VOA-basis, as shown in FIG. 3 j, such that all areas that have beena part of a present or previous VOA that caused a side effect arehighlighted as a side effect area, even if the side effect did not occurin that particular area, unless the area is also associated with atleast one other VOA that has not caused any (or significant) sideeffect. This may be helpful to the user by indicating those areas whichmay be stimulated without causing a side effect. A user may therebydetermine areas in which to avoid stimulation.

For example, if a first stimulation results in a side effect, then theentire corresponding VOA can be labeled, shaded, or otherwise identifiedusing the side effect feature. If a second stimulation corresponding toa VOA overlapping with the first VOA at least in part does not includethe side effect, then the area not having the side effect is notlabeled, shaded, or otherwise identified as having the side effect, suchas shown in FIG. 3 j as the gray areas within the yellow areas. Forexample, if the stimulation not having the side effect is modeled afterthe stimulation having the side effect, the area corresponding to thefirst modeled stimulation field can be modified so that its shading isremoved in that portion at which the second modeled VOA overlaps thefirst VOA. In various examples, the side effect area or structure canshow a single side effect over multiple stimulations, or the side effectarea can show multiple side effects over multiple stimulations. In anexample, multiple side effects can be recorded for a single stimulation.In certain examples, as overlapping VOAs are recorded, separate orcombined side effect areas can be created illustrating areas ofstimulation corresponding to a specific or single side effect, or acombination of multiple side effects.

In other examples, a benefit area or structure, or a mold illustratingno noticeable effect can be created in a similar fashion. In an example,at least two of the benefit area, the side effect area, or the areaillustrating no noticeable effect can be created or shown.

In an example, for any one or more of the molds, the side effects can bedistinguished as having varying levels of effect or severity. In otherexamples, one or more structures can be identified in relation to abenefit or side effect, in conjunction with, or instead of itsanatomical name. In an example, the label (e.g., a color, a shade, etc.)of a structure can be affected by a degree or severity of the benefit orside effect. In an example, the greater the benefit or the worse theside effect, the darker or lighter the color or shading.

In an example, the benefit mold, the side effect mold, or the moldillustrating no noticeable effect can include a patient specific mold, apopulation mold, or a mold of one or more stimulations from one or morepatients.

Time Series VOA

In an example, a VOA is a representation of the volume of tissue thatcan be activated at a single point in time. In certain examples, the VOAcan represent the predicted volume of tissue activated by a waveformwith a specified maximum amplitude (e.g., the stimulation waveform). Inan example, a biphasic square wave can be applied at a constantfrequency. In an example, a therapy may include delivery of stimulationaccording to different parameters at different pulses. For example, afirst frequency and/or electrode combination may be used for a firstpulse, and a different frequency and/or electrode combination may beused for a second pulse. In another example, a pattern of varyingfrequencies that repeats over a certain number of pulses may be used. Inanother example, the frequency used may be sufficiently high as that aninitial stimulation causes the cells to be in an absolute or relativerefractory period during the subsequent stimulation and thus vary theVOA over time. Because a pulse generator can be capable of deliveringdifferent waveforms at different frequencies in a therapy, it can bedifficult to pick a single point along the time series of stimulation ata specific time during the pattern that can be representative of theentire stimulation protocol for creation of a VOA.

In an example embodiment of the present invention, a Time Series VOAfeature is provided that allows a user to cycle (automatically ormanually) through a sequence of patterns to show the potential VOA ateach different stimulation pulse. This can be particularly importantwhen different amplitudes or pulse widths are used for pulses ofdifferent frequencies. The Time Series VOA may allow the user to cyclethrough the waveform and select different time points along thewaveform. For each point, the VOA may be calculated based on theamplitude or total amount of charge delivered at that time. This can beshown in a variety of different ways, including a series that can beclipped or played where the VOAs are updated based on the timed patternwith respect to a timeline that a user can click or based on clicking ordragging across positions on the displayed pattern or waveform to showthe VOA at any point within the pattern, etc. In an example, the VOAscan be played back as a movie. Alternatively, the user can selectdiscrete points for display of the corresponding VOA. For example,selectable icons or other graphical components associated with the VOAsmay be displayed, in response to whose selection, the system may displaythe corresponding VOA. Further, the components may be displayedaccording to the sequence in which the parameters corresponding to theVOAs are applied for the therapy. For example, they may be displayedalong a timeline.

Another possible way to display this would be as a single volume whichis the main volume of tissue stimulated. If this does not encompass asufficient amount of information, it would also be possible to displaythe VOA as a gradient or with fuzzy boundaries.

When displaying VOAs for interleaved pulse widths, VOAs caused bydifferent frequency parameter sets may be displayed in different colorsso that the user can differentiate which areas are being affected bywhich parameters and be better able to change any regions which areunsatisfactory.

Programming Interface

Referring again to FIG. 3 e, in an example embodiment of the presentinvention, a system may be configured to display a user-interactiveinterface including, e.g., three vertical sections. As shown in FIG. 3e, the far left section includes a program selection area 3000 having atleast one program 3001 (an electrode leadwire parameter set, e.g.,including a combination of amplitude, rate, pulse width, and electrodecombination) to be selected, activated, and/or simulated. The middlesection includes a directional programming area 3002 illustrating anexample model of an implantable leadwire having one or more electrodecontacts that can be selected, activated, or otherwise changed. In theexample shown in FIG. 3 e, the leadwire model includes eight electrodes3008. The far right section includes a modeling area 3004 having anexample of a 3-D model including an implantable leadwire and anestimated VOA 3005.

In an example embodiment, a unique mark may displayed in the leadwiremodels of areas 3002 and 304 to visually indicate how a model 2-Dleadwire model in area 3002 rotationally corresponds to the modelleadwire in area 3004. For example, the a mark, e.g., a square may bedisplayed at the top-right electrode shown in area 3002. The mark mayalso be shown at a location of the model leadwire shown in area 3004that corresponds to the top-right electrode shown in area 3002.

In an example embodiment, in the program selection area 3000, for eachselectable program 3001, there may be displayed a battery status area3006, including the current available battery percentage of an IPGconfigured to deliver an electrical stimulation pulse, as well as anestimated remaining battery life of the IPG should the selectableprogram be activated.

In this example, the program selection area 3000 includes fourselectable program spaces, three of which have been programmed. Program1 is shown to be active. Programs 2 and 3 are programmed but not active.Program 4 has not been programmed and is not active. In an example,while Program 1 is active, Programs 2-4 can be programmed, reprogrammed,or otherwise altered or changed in a preview mode. During each programchange, the program selection area 3000 can update the battery status orestimated remaining battery life for the selected or previewed program3001.

In certain examples, Program 1 can be altered while it is active, withor without immediately changing the programming instructions to thedevice. In an example, Program 1 will continue unaltered, despite thechanges to Program 1 in the programming window, until a STOP button orother selection to activate changes is selected. In alternative exampleembodiments, the changes to an active program can be delivered to theIPG as they are changed.

In an example embodiment, the middle directional programming area 3002can be used to alter or change the settings of one or more electrodes ona leadwire for the program 3001 selected in the program selection area3000. In an example, one or more electrodes can be selected to be acathode or an anode, or multiple electrodes can be selected to be acombination of one or more cathodes or anodes. In the example of FIG. 3e, three of eight electrodes are selected as anodes in a monopolarconfiguration.

In an example embodiment, the interface is configured such that thecurrent for the leadwire can be selected, such that the amplitudes ofthe respective electrodes are modified to obtain the selected current.The interface may be further configured such that after the current forthe leadwire is selected, amplitudes of individual electrodes may beselected, in which case the system may update the value of the leadwirecurrent accordingly. In the example of FIG. 3 e, the current for theleadwire can be selected using a current selection button 3007 (shown asone of the toolbar buttons immediately below the illustrated selectabletabs).

In an example embodiment, the status of each electrode or current to bedelivered to each electrode can be individually selectable. For example,selecting an electrode 3008 can change the electrode 3008 from off toactive as an anode (e.g., in the bipolar arrangement), from active as ananode, to active as a cathode, from active as a cathode to off, etc.,the order being exemplary. In an example, once active, either positiveor negative, a stimulation current amplitude can be selected. In certainexamples, the current to be delivered (e.g., negative for an anode,positive for a cathode) for an active electrode can be displayedalongside the electrode as shown in FIG. 3 e, or can be altered orchanged from its current value (e.g., using arrows 3010 or other means,such as being directly input).

In FIG. 3 e, three electrodes 3008 are shown to be active. For each ofthe three electrodes 3008, its respective current is displayed adjacentthe electrode 3008 sandwiched between up and down arrow buttons 3010selectable for, respectively, increasing and decreasing the electrode'scurrent. It is noted that the particular values in FIG. 3 e may beimprecise. For example, as indicated above, the individual amplitudes ofthe electrodes 3008 may add up to the overall current value shown in thecurrent selection button 3007.

In an example, the direction of the current field can be altered, suchas by using arrows to direct adjacent or other electrodes (previouslyactive or off) to assume at least a portion of the current of theirneighboring electrode. For example, two directional input buttonsdisplayed above and below the model leadwire may be used to shift thecurrent field(s) upwards or downwards. In the example of FIG. 3 e, fourdirectional input buttons 3012-3015 are shown for shifting the currentfield(s) upwards, downwards, to the left, and/or to the right. If thelocation of the current is desired to be lower, the down arrow button3015 at the bottom of the directional programming area 3002 can beselected, and at least one of the contact configuration and stimulationamplitude may be altered in such a way as to increase activation oftissue in the selected direction and decrease activation of tissue inthe opposite direction. For example, with respect to FIG. 3 e, both ofthe current fields 3020 may shift downwards in response to the selectionof the button 3015. In other examples, if the down button 3015 isselected, all of the current from the previous configuration can betransferred entirely to adjacent electrodes 3008 in the selecteddirection. In other examples, the field can be stretched, expanded, orshrunk in a similar fashion. For example, additional or alternative,e.g., directional, controls may be provided for the stretching orshrinking in a particular direction.

In an example embodiment, if a program is active, each button oreditable field can be a first color to reinforce that the changes beingmade are to an active stimulation program, such that they can beimplemented as they are changed, or can be implemented after making thechanges, calculating or simulating a predicted area of activation orstimulation field, and accepting the one or more changes. If a programis inactive, each button or editable field can be a second color toreinforce that the changes being made are to an inactive stimulationprogram.

In other examples, the directional programming area can include a 3-Drendering of a leadwire having one or more electrode contacts. Further,one or more other stimulation parameters, such as a pulse width, afrequency, etc., can be set, established, changed, or altered.

In an example embodiment, the modeling area, as further described above,can include at least one of a 3-D model and one or more medical imagesof a patient's anatomy, an overlaid leadwire model, and a VOA, e.g.,corresponding to the parameters input in the directional programmingarea. As one or more of the stimulation parameters or electrodeconfigurations of the selected program changes, the modeling area cangraphically illustrate the estimated effects of such parameters orconfigurations.

In the example of FIG. 3 e, a 3-D model illustrates an implantedleadwire in the sub thalamic nucleus (STN) of a patient. In an example,a VOA (illustrated in FIG. 3 e as the circle shown around a portion ofthe leadwire) can be calculated for a given set of programmingparameters (e.g., Program 1, Program 2, Program 3, etc.).

In an example embodiment of the present invention, the current fieldsand/or the VOAs may be shifted by a drag-and-drop function, e.g.,performed via a mouse, stylus, touch-screen, or any other suitablyappropriate device.

3-D Current Steering Using a Directional DBS Lead

In an example embodiment of the present invention, a directionalstimulation leadwire has four electrode contacts located rotationallyaround the leadwire. FIG. 17 shows a leadwire and electrodes 1701-1704.The leadwire is attached to a generator that allows for independentcurrent sources on each electrode contact individually. In the exampleembodiment, there are several ways the field can be manipulated. Lookingin two dimensions, the field can be moved either up or down the leadwirein the Z direction by hitting directional up or down arrow buttons 3013and 3015 as shown in FIG. 23, respectively, above and below the modelleadwire. The field can be moved side to side in the X direction byhitting directional side to side buttons 3012 and 3014 as shown in FIG.23. The field can also be moved rotationally around the leadwire byhitting a clockwise or counterclockwise directional button (not shown)and/or manipulating a rotational knob or wheel, and/or a joystick. Ineach case, there is an algorithm that controls the movement of thestimulation field by changing the amount of current delivered to a setof electrodes to either a different amount of current to some or eachelectrode or a different combination of electrodes. The view as shown inFIG. 23 can be rotated either gradually or by 90 degree (or some othernumber of degrees) increments in order to see all angles of thestimulation field, e.g., in the directional programming area 3002 andthe modeling area 3004 as shown in FIG. 3 e. Additionally, the view canbe shown in conjunction with an overall orthogonal view or across-sectional view having a particular cross-section in the orthogonaldirection, so all three dimensions can be seen simultaneously by lookingat multiple 2-D views. Where a cross-sectional view is shown, in anexample embodiment, the system may include a control, e.g., theselectable slice bar 3031, for selecting a particular cross-section.

With respect to the cross sectional view of the stimulation leadwire, asshown in FIG. 18, and the stimulation field, there are several ways ofsteering the stimulation field with a directional input. As shown inFIG. 19, an example embodiment of the present invention allows for agradual and smooth adjustment of the current field from position 1900 ato position 1900 b, and then to position 1900 c along the X axis. (Thiscan be similarly done along the Y axis.)

As shown in FIG. 20, an example embodiment of the present inventionallows for a quick adjustment along the X axis by transposing thecurrent field about the Y axis from position 2000 a to position 2000 b.(In an example embodiment, this can be similarly done along the Y axisby transposing about the X axis.)

Similarly, as shown in FIG. 21, rotational input allows for movement ofthe current field rotationally about the Z axis from position 2100 a toposition 2100 b, and then to position 2100 c.

An example embodiment of the present invention provides for 26 basiclinear directional inputs that can be used to steer a current field fora leadwire, as shown in FIG. 22. For example, the stimulation leadwireis in the center of the cube shown in FIG. 22. Each set of directionalinputs can be displayed separately or in combination with another set.The first set of inputs is directed toward the vertices (8), another setof inputs is directed perpendicular to each face (6), and additionallyanother set of inputs is directed toward the midpoint of each side orarête (12). In addition, two rotational directional inputs can be used(clockwise and counterclockwise) for rotational movement as shown inFIG. 21.

While the above examples have been discussed in connection with anarrangement including four electrodes located rotationally around theleadwire, other embodiments may include an arrangement having otherconfigurations such as, for example, three or five electrodes locatedaround the leadwire.

Some electrode arrangements may include a split of the electrodes withfour electrodes extending less than 360° about the circumference of theleadwire as shown in FIGS. 17 and 23. Others may instead include, e.g.,one cylindrical electrode surrounding the leadwire. In an exampleembodiment of the present invention, a system and method includes anoperation for controlling the multiple electrodes as shown in FIGS. 17and 23 as though they were a single cylindrical electrode. When usingthis operation, the parameters for adjusting the electrodes may beuniformly applied to a group of electrodes surrounding the lead at thesame coordinate in the Z direction.

In addition to a directional input for redistributing current from oneset of electrodes to another, other methods can be used such as:

-   -   rotating the 3-D view of the leadwire and brain structure so the        intended direction of stimulation is to the left or right of the        leadwire and manually select the location to which to move the        current field;    -   touching/selecting the structure or the structure name towards        which the current field is desired to be directed, and then,        e.g., the system automatically, increasing or decreasing the        overall amplitude or intensity (this may include increasing the        amplitude on more than one electrode simultaneously) in order to        fill the intended stimulation target; and/or    -   displaying a grid of nodes throughout the 3-D field that can be        selected in order to steer the current field toward one of the        nodes in 3 dimensions.

In an example embodiment of the present invention, the system mayprovide for receipt of user input for steering a displayed VOA, e.g., asdisplayed in the modeling area 3004, and responsively select theelectrode parameters which result in the shifted VOA. The system mayalso responsively move the current field(s).

Thus, the steps detailed below represent one possible method forprogramming a leadwire in 3-D according to an example embodiment of thepresent invention (the sequence of some of the steps may be changed andvarious steps, e.g., the display of side effect volumes, may beomitted):

-   -   1. acquire imaging data (MRI, CT, other);    -   2. fuse imaging data (MRI and CT, other);    -   3. register a 3-D atlas to patient data;    -   4. display:        -   a. a 3-D view of the atlas;        -   b. a 3-D target VOA;        -   c. 3-D side effect volumes;        -   d. a 3-D view of the leadwire;        -   e. a cross sectional view of the leadwire; and        -   f. an initial model stimulation field;    -   5. receive input, e.g., via selection of one or more of six        linear directional inputs (left, right, up, down, and the two        directions extending into and out of the screen and orthogonal        to the other four directions) and/or one of two rotational        inputs (clockwise, counterclockwise), for moving the displayed        stimulation field until the stimulation field is located        approximately at the target stimulation field; and    -   6. increase/decrease the intensity in order to best fit the fill        of the target stimulation volume.

Another method, according to an example embodiment of the presentinvention, is to:

-   -   1. acquire imaging data (MRI, CT, other);    -   2. fuse imaging data (MRI and CT, other);    -   3. register a 3-D atlas to patient data;    -   4. display:        -   a. a 3-D view of the atlas;        -   b. a 3-D target VOA;        -   c. 3-D side effect volumes;        -   d. a 3-D view of the leadwire;        -   e. a cross sectional view of the leadwire; and        -   f. an initial model stimulation field;    -   5. automatically calculate the settings that create a best fit        of the stimulation field to the target stimulation field;    -   6. receive input, e.g., via selection of one or more of six        linear directional inputs (left, right, up, down, into or out of        the screen) and/or one of two rotational inputs (clockwise,        counterclockwise), for making manual adjustments to move the        stimulation field until the stimulation field is located        approximately at the target stimulation field; and    -   7. increase/decrease the intensity in order to best fit the fill        of the target stimulation volume.

Method of Implanting a DBS Leadwire

A method of implanting a DBS leadwire has been described for examplewith respect to FIGS. 5 and 6. Additionally various methods ofestimating VOAs, selecting optimal stimulation parameters, and modifyingparameters affecting location and size of VOAs have been described. Inan example embodiment of the present invention, these various methodsmay be used to perform a method of implanting a DBS leadwire. A methodof implanting a DBS leadwire according to an example embodiment of thepresent invention is to (the sequence of some of the steps may bechanged and various steps, e.g., the display of side effect volumes step5(c) and/or the stimulation to verify position step 17, may be omitted):

-   -   1. acquire imaging data (MRI, CT, DTI, other) (various forms of        data can be acquired such as MRI with a headframe or CT with a        headframe and MRI without a headframe);    -   2. fuse imaging data (MRI and CT, other) including MRI data with        surgical headframe;    -   3. display a 2-D and/or 3-D atlas;    -   4. automatically and/or manually stretch, translate, rotate,        deform, and fit the atlas to the patient's brain structures;    -   5. display at least one of:        -   a. a 3-D view of the atlas;        -   b. a 3-D target stimulation field (e.g., based on a database            of previous patients programming); and        -   c. 3-D side effect volumes (e.g., based on a database from            previous patients programming);    -   6. determine a surgical plan for placing the DBS leadwire,        including determination of:        -   a. location of burr hole;        -   b. angle of entry; and        -   c. track of leadwire from burr hole to target;    -   7. display one or more leadwires in 3-D in the 3-D view of the        atlas;    -   8. simulate possible VOAs in the target stimulation volume for        each of the one or more leadwires, including to:        -   a. manually adjust the leadwire location (angle, depth,            etc.) and stimulation settings to get best coverage of the            target stimulation volume; and/or        -   b. autofit to best VOA and leadwire location;    -   9. automatically and/or manually analyze leadwire locations and        VOA's of step 8, and determine and select best leadwire,        location, and stimulation settings;    -   10. create burr holes;    -   11. perform MER recordings;    -   12. enter MER data into software or automatically acquire the        data (if data is auto acquired the brain structures would be        auto identified as well);    -   13. adjust the atlas to fit MER recording data:        -   a. manually;        -   b. automatically;        -   c. using linear scaling; and/or        -   d. using non linear statistical methods;    -   14. recalculate or adjust and display the target stimulation        volume according to the adjusted atlas;    -   15. recalculate which leadwire is to be implanted, the optimal        location, and optimal stimulation settings as described in steps        8 and 9;    -   16. insert the leadwire; and    -   17. stimulate to verify positioning.

Method of Programming a DBS Leadwire

As described above, method according to example embodiments of thepresent invention may provide for estimation of VOAs for certainparameter settings. Similarly, parameter settings may be estimated for aselected VOA. Moreover, for a target activation region, the system mayestimate the possible VOAs close to the target activation region forvarious possible parameter settings. The target activation region may beone selected with respect to a model of the patient anatomy, e.g.,without regard to the particular placement of the leadwire. The systemand method of the present invention may, based on the leadwire locationand configuration, determine estimated parameter settings for anestimated VOA closely corresponding to the target region. A clinicianmay subsequently test the system-suggested parameters or similarparameters, and adjust the parameters using some of the methodsdescribed above, since the resulting benefits and side effects may bedifferent than those anticipated by the system. For example, the actualVOA may be different than the estimated VOA.

Accordingly, a method of programming a DBS leadwire, e.g., subsequent toimplantation of the leadwire in a patient's brain, according to anexample embodiment of the present invention is to (the sequence of someof the steps may be changed and various steps, e.g., step 2(e), may beomitted):

-   -   1. obtain, e.g., by receipt of user-input or by importation of a        file, folder, or other data structure from a surgical planning        system, surgical planning data including but not limited to:        -   a. imaging data;        -   b. atlas location;        -   c. a surgical plan;        -   d. MER data;        -   e. leadwire location and type; and        -   f. initial stimulation parameters, e.g., those determined            via the system estimations for a target stimulation volume;    -   2. display the following:        -   a. a 3-D atlas;        -   b. a 3-D leadwire;        -   c. the target stimulation volume;        -   d. the initial stimulation parameters; and        -   e. the estimated VOA(s) for the initial stimulation            parameters;    -   3. test initial stimulation parameters;    -   4. obtain additional possible stimulation parameter sets, the        determination including one of:        -   a. monopolar review (a wizard is included in the software            for stepping through a parameter setting for each electrode            separately);        -   b. propose stimulation settings based on an algorithm to            minimize the number of settings to get to the best            therapeutic outcome;        -   c. other regimented sequence of initial programming            parameters; and        -   d. combination of ‘a’ and ‘b’ where ‘a’ is performed and            then ‘b’ to further narrow the field;    -   5. test the various proposed stimulation settings obtained in        step 4;    -   6. during each test of a stimulation setting, receive input        regarding, and record, the following:        -   a. benefits of the stimulation—each benefit individually and            quantitatively; and        -   b. negative effects of the stimulation—each side effect            individually and quantitatively;    -   7. the system calculates and displays the following based on the        tested parameters and the received input regarding the test        results:        -   a. volume of tissue that has been explored, e.g., using the            flashlight feature:            -   i. 2-D for each MRI slice; and/or            -   ii. 3-D;        -   b. for each benefit, a target stimulation volume by finding            an overlap in volumes where benefits were observed and a            subtraction of volumes where benefits were not observed:            -   i. 2-D for each MRI slice; and/or            -   ii. 3-D;        -   c. for each side effect, a side effect volume by finding an            overlap in volumes where side effects were observed and a            subtraction of volumes where side effects were not observed:            -   i. 2-D for each MRI slice; and/or            -   ii. 3-D;    -   8. based on the noted benefits and side effects relative to the        various tested VOAs, the system determines and displays:        -   a. a new target stimulation volume for each benefit            individually;        -   b. a collective target stimulation volume that incorporates            an addition of all the volumes of step 8(a);        -   c. side effect volumes for each individual side effect;            and/or        -   d. a collective side effect volume that incorporates the            addition of all side effects volumes of step 8(c);    -   9. the system estimates and outputs:        -   a. stimulation settings that result in a VOA that fills the            intended benefit volumes without filling the side effect            volumes for a specific benefit; and        -   b. stimulation settings that result in a VOA that fills the            intended benefit volumes without filling the side effect            volumes for a collective therapy where:            -   i. for example in Parkinson's, a particular benefit such                as tremor may be weighted differently than rigidity, the                goal of the stimulation settings being to optimize the                total benefit to the patient;            -   ii. benefit profile can be user defined based on the                patient's needs; and            -   iii. a benefit index is developed based on initial user                inputs and patient desires;    -   10. after the target stimulation volumes and the side effect        volumes are calculated the user can input, via a user interface,        instruction that:        -   a. have the positioning of the atlas automatically updated            based on the volumes; or        -   b. manually move the atlas to position the atlas to better            correlate to the volumes;    -   11. for each set of parameter settings tested subsequent to the        initial performance of step 8, update the explored volumes of        tissue and the targeted stimulation volume;    -   12. optionally save different benefit profiles either on the IPG        or in the patient or clinician programmer system, where profiles        may include:        -   a. a tremor control profile indicating, for a tremor control            therapy, a targeted stimulation volume, suggested            parameters, and/or corresponding estimated VOA for best            filling the targeted stimulation volume;        -   b. a rigidity control profile indicating, for a rigidity            control therapy, a targeted stimulation volume, suggested            parameters, and/or corresponding estimated VOA for best            filling the targeted stimulation volume; and/or        -   c. a patient total benefit index profile indicating, for            total patient benefit, a targeted stimulation volume,            suggested parameters, and/or corresponding estimated VOA for            best filling the targeted stimulation volume; and    -   13. at the end of a programming session, sync, by the physician,        the software, to a database that will automatically update the        data set for determining the initial target stimulation volume        for a particular therapy and the side effect volumes.

For example, with respect to steps 4 and 5, the monopolar review mayinclude initially setting the electrode current values to zero, andstepping up the value of one electrode incrementally. For example, thevalue for the subject electrode may be increased, while the values ofthe other electrodes remain the same. This may be separately repeatedfor each electrode. For each step, the setting may be tested todetermine whether it causes a side effect. In this way, the cliniciancan get a good idea of the upper limits of, for example, the amplitudevalues to be applied to the various electrodes.

With respect to step 4(b), instead of stepping incrementally through thevarious values for each electrode, one set increment at a time, thesystem may incorporate user input indicating results of a previoussetting to skip through certain settings. For example, if a certain typeof a severe side effect is indicated by the clinician to have occurredwhen the value of electrode 1 was at value four, the system maydetermine that a similar side effect is likely to occur at values fiveto eight, and may therefore skip to value nine. Alternatively or inaddition, the system may begin at or near the initial estimatedstimulation parameters and continue with the monopolar review from thoseinitial settings.

With respect to step 9, estimation equations, e.g., as described abovewith respect to the monopolar and bipolar configurations, may be used.

With respect to step 10, where a target stimulation volume determined atstep 8 differs from an initial target stimulation volume, which may bebased on data concerning multiple patients, it may be determined thatthe patient atlas obtained at step 1 is likely to be incorrect. At step10, the atlas may be adjusted in view of such discrepancies. Forexample, if the new target stimulation volume is slightly shifted to theright from the initial target stimulation volume, anatomical structuresof the atlas may be shifted so that the new target stimulation volume isshifted to the left.

Patient Monitoring and Interaction

In an example embodiment of the present invention, the system isconfigured to store or log information (e.g., received information,sensor information, stimulation parameter information, such asstimulation duration, cycling parameters, etc.). In certain examples,the system is configured to receive, store, and/or display user orpatient information (e.g., comments) regarding the user or patient'sobservation of the efficacy of therapy, therapy benefits, noticed sideeffects, etc.

In an example embodiment of the present invention, the system isconfigured to include data input or data analysis capabilities. In anexample, the system includes one or more sensors used for the data inputor analysis capabilities. In an example embodiment, the system isconfigured to receive information from at least one sensor or otherinstrument coupled to the clinician programmer system (e.g., anesthesiaor other monitoring equipment). For example, the clinician programmersystem can intra-operatively receive data input from an anesthesia cart.

In an example embodiment, the clinician programmer system (or anothercomponent communicatively coupled to the clinician programmer system)includes a camera, video camera, audio recorder, and/or other sensorconfigured to take or receive a still, moving, and/or other image,video, and/or audio of the patient, the patient's surroundings, etc.

In an example embodiment, the one or more sensors of the clinicianprogrammer system or of another system or device coupled thereto includean accelerometer, a force transducer, a temperature sensor, and/or othersensor configured to sense physiological or other information from apatient or the patient's environment or otherwise receive input on apatient's recovery. In an example, the accelerometer, force transducer,or other sensor can be used as part of a rehabilitation routine.

In example embodiments, the physiological sensors of or coupled to theclinician programmer system may include, e.g., a brain activity sensor(e.g., one or more electrodes configured to detect brain activity,etc.), an EEG sensor, a cardiac sensor (e.g., one or more sensorsconfigured to detect a depolarization, or other information, of theheart, etc.), a pressure sensor (e.g., a blood pressure, etc.), arespiration sensor (e.g., a tidal volume sensor, etc.), an impedancesensor (thoracic impedance, etc.), an activity sensor (e.g., anaccelerometer or other activity, posture, sleep, or other sensorconfigured to receive information about the level or state of activityof the patient), and/or other physiological sensor configured to senseor receive physiological or other information from the patient.

In an example embodiment, the clinician programmer system is configuredto receive information from the sensor(s), and analyze or store theinformation, for example, to establish a medical history of the patient(e.g., establish a log for a specific patient for a clinician or otheruser to review), for later analysis by a clinician or other user (e.g.,to monitor stimulation efficacy, etc.), to suggest or alter astimulation setting or parameter, or for other uses.

The data from the sensors can be stored on the clinician programmersystem and tracked over time to see how the patient is doing with theirstimulation in conjunction with rehabilitation. In certain examples, thecamera, video camera, audio recorder, or other sensor configured to takeor receive the still, moving, and/or other image, video, and/or audio ofthe patient can be configured to actively or passively monitor thepatient (e.g., patient progress, condition, etc.), receive informationfrom the patient (e.g., information from a query), or otherwise monitoror record information from the patient for immediate or later medical orother uses.

For example, in an embodiment in which the system includes a camera(e.g., video and/or still), the camera can be used to document patientprogress, or to observe patient performance as they respond toinstructions or to different stimulation parameters or settings. Incertain examples, the images and/or video can be stored, e.g., for laterreview or use, such as to judge the effectiveness of certain stimulationsettings. In other examples, the images and/or video can be time stampedand can be compared to other physiological information (e.g., EEG,etc.).

In an example embodiment, the one or more sensors can be used toevaluate the efficacy of certain programming parameters, such as byreceiving information in response to certain (e.g., predefined, known,etc.) patient tasks in order to evaluate patient status (e.g., tomonitor overall patient status or improvement, to monitor patient statusor improvement since the patient's last office visit, etc.). Forexample, sensors may be used to obtain physiological data while thepatient performs the task and the obtained data may be compared tovalues expected for the performance of the task. For example, the taskmay be to pull on a strain gauge in order to measure the patient'sstrength. In another example, a temperature may be used to sense thepatient's temperature while performing a certain task. In anotherexample, motion sensors may be used to record information, e.g., speed,force, and/or duration, regarding the patient's motion when performing acertain task, e.g., lifting a certain object over the patient's head.

In an example embodiment of the present invention, the system includes aquery module configured to provide a query to a user or patient andreceive an answer to the query. In various examples, the query modulemay be configured to deliver a video, text, audible, and/or graphicalquery to the user or patient. In certain examples, the query can includeinformation regarding generally physiological or personal information, atherapy efficacy, a noticed side effect, etc. In an example embodiment,the system is configured to receive and record the answer to the query,e.g., for later review or use, such as to judge the effectiveness of atherapy and/or of certain stimulation settings, to suggest furtherprogramming changes, etc.

The query may be for, for example, a Barthel index activity query forwhich answers include a numeric metric indicating degree. For example, aquery may be regarding feeding of the patient, where 0=unable, 5=needshelp, and 10=independent. Other metrics may be used for other examplequeries.

The query can be given by a clinician in direct (office visit) orindirect (through email, phone, or other communication) contact with thepatient, or the query can be given by the clinician programmer system orother device in contact with the patient (e.g., a patient programmersystem coupled to the clinician programmer system).

In an example embodiment of the present invention, the system isconfigured to store any received information, such as received sensor,video, query, or other received information. The system may beconfigured to organize the received information and/or display theinformation (e.g., in an easy-to-interpret graphical fashion). Incertain examples, the system is configured to store some or all of theinformation, received or derived, locally on the clinician programmersystem, or some outside device can store some or all of the information.

In an example embodiment of the present invention, a system includes aclinician programmer system and/or terminal as well as a patientprogrammer system and/or terminal. In an example, the patient programmersystem is configured to receive information from the IPG or other sensorand communicate the information to the clinician programmer system. Inother examples, the clinician programmer system is configured tocommunicate queries, programmer settings, and/or other information tothe patient programmer system for display at the patient programmersystem to the user, and/or upload to the IPG or other sensor. Forexample, the system is configured to receive stimulation parameters fornew wave shapes and patterns. Once entered, the system is configured toprovide for the new wave shape or pattern to be uploaded to the IPG orother therapy delivery module for delivery to the patient. In anexample, the patient programmer system is configured to allow a patientto change, alter, or otherwise adjust one or more therapy parameters,such as an on/off state, or other acceptable stimulation parameters,e.g., within safe operating guidelines.

In an example embodiment of the present invention, the clinicianprogrammer system is configured to automatically adjust one or moretherapy parameters, e.g., based upon patient status or physiologicalconditions, etc.

FIG. 8 illustrates generally an example of a method 800 includingdownloading data from the IPG, analyzing downloaded data, and adjustingparameters based on data analysis.

At step 805, data from the IPG is downloaded. In an example, the datafrom the IPG includes physiological data of the patient, therapyparameters, or IPG status information (e.g., battery status, leadimpedance, etc.).

At step 810, the downloaded data is analyzed.

At step 815, parameters are adjusted based on data analysis. In thisregard, it is noted that VOA, benefit, and side effect estimations maybe used to initially select parameters, but the parameters may besubsequently adjusted in view of results of actual stimulations. In anexample, the duty cycle, and consequently, other therapy parameters, canbe adjusted to save power, yet yield optimal therapy given the powerconstraints. In other examples, other parameters, such as electrodeconfiguration, etc., can be manually or automatically adjusted dependingon received information (e.g., lead impedance, etc.).

Patient History Functions

In an example embodiment of the present invention, the system isconfigured to sense, and/or otherwise receive, store, and/or track overtime, one or more physiological measurements, parameters, and/or otherinformation of a patient. In an example embodiment, the system mayinclude a patient history application for such functions. For example,information from each patient inquiry, checkup, visit with a physicianor other caregiver, etc., can be stored and saved using the system ofthe present invention.

FIGS. 11-12 illustrate example screenshots of system output for patienthistory functions.

For example, the information from each inquiry, such as the clinicianprogrammer stimulation settings, can be displayed as a thumbnail view,such as the thumbnails 1202 shown in the “Program” timeline 1200 in FIG.12. An inquiry or session may be that which is defined in memory as asession structure, e.g., a defined folder. In an example embodiment,therapeutic stimulation delivery may be conducted in sessions at apatient terminal. Information recorded during those sessions may bestored on a session basis. The stored sessions may be transmitted to aclinician programmer terminal at which the patient history functions maybe performed using those received session data. Alternatively, sensorsat the patient terminal may be time-stamp recorded data and theclinician programmer terminal may use the time-stamps to arrange thedata in sessions. The patient terminal may be, for example, a portableterminal used by the patient on a daily basis. For example, the devicemay attachable to the patient's body. In addition, the various sensorsmay also be portable sensors, e.g., attached or attachable to thepatient's body. Alternatively, the therapy delivery and the patienthistory functions may be performed at the same terminal.

In an example, the thumbnails may be provided such that, with scrollingalong the Program timeline 1200, thumbnails may be removed from displaywhen scrolled past an edge location of the timeline. In certainexamples, with continued scrolling along the timeline 1200, thethumbnail may be re-displayed at an opposite edge of the screen, so thatit appears to have been scrolled about the screen. In certain examples,certain ones of the thumbnails 1202 may be displayed to show itsrespective detailed information, while other are displayed as thoughrotated so that only a side-profile outline, shown as lines 1204 in FIG.12, are displayed.

In certain examples, until a thumbnail representing an inquiry isselected, and not hidden or rotated, other information can be shown andtracked, e.g., in the form of various graphs of values against time,while the specific values from a specific inquiry are not shown. In anexample, the thumbnails 1202 and corresponding detailed values of thefirst inquiry and/or the last inquiry can be shown by default, such asshown in FIG. 12. In an example embodiment, a dark highlight bar can beused to illustrate selection of a point along the timeline correspondingto a selected thumbnail, such as shown in FIG. 12. In one example, thehighlight bar may be moved across the timeline, as the user scrollsthrough the thumbnails.

In an example embodiment, the patient history application is configuredto compare numerically and/or graphically historical metrics of aphysiological parameter or other sensed or generated information for thepatient (e.g., a simulated or actual VOA, etc.). The patient historyapplication may allow a user to select one or more metrics (e.g.,historical metrics) to track on a per-patient basis. For example, FIG.12 shows graphs for impedance, battery life, and a functional impedancemeasure. The system tracking aspects enable a user to customize themetric to focus on the patient's therapy and symptoms or otherindications. In an example embodiment, the system may store groups ofsuggested tracking aspects on a per therapy or symptom basis, selectableas a whole by a user. In certain examples, the one or more metrics canbe individually selectable and/or created by the user as the user seesfit.

The historical metric can be selected to display information from one ormore previous sessions (e.g., the previous 3 sessions, the first and thelast session, etc.). In an example, the system is configured to providefor comparison of one or more previous session information to a baselineor for the information to otherwise be displayed over several months oryears, or through the timeline of the one or more selected sessions. Forexample, a baseline thumbnail may be continuously displayed, even as theuser scrolls through the Program timeline to display different ones ofthe thumbnails corresponding to prior sessions. Further, the patienthistory application allows the user to zoom in on a specific day orother time period (e.g., days, hours, etc.) in conjunction with, orseparate from viewing the longer timeline (e.g., the several months oryears, or through the timeline of the one or more selected sessions).For example, an initial timeline representing a first time period may bereplaced by another timeline representing a shorter or longer timeperiod depending on whether the user as zoomed in or out.

In an example, the system is configured to output an alert when one ormore parameters are out of a normal or otherwise defined specification,threshold, or boundary of the therapy or system. For example, the systemmay store information regarding ranges of normal or desired/requiredvalues for various parameters for comparison to actual values. FIG. 11,for example, shows displayed alerts 1120. In one example, the storedvalues may vary depending, e.g., on a particular therapy, symptoms,and/or patient. In an example, the alert is configurable to graphicallydisplay negative trends or times while the one or more parameters areout of the normal or otherwise defined specification, threshold, orboundary of the therapy or system.

In an example, the patient history application includes a comparisonfeature that allows the user to quickly and accurately determine if thedevice and/or patient symptoms are changing over time (in either apositive or negative perspective). For example, any change in a positiveor negative direction for a value of one or more parameters may beflagged, even if not out of a tolerance range. For example, FIG. 11shows arrows 1100 showing used for flagging such changes.

In an example, one or more metrics can include physiologicalinformation, device information, and/or one or more other types orcategories of information, such as a stimulation setting or parameter,etc. The one or more metrics can be displayed graphically or otherwisepresented to a user, such as is shown in FIG. 12. Further, notes can beinput, received, or stored, such as shown in FIG. 12, e.g., in atimeline 1206 corresponding to the displayed thumbnails.

In an example embodiment of the present invention, thumbnails may bedisplayed in date order, without a timeline, i.e., without an indicatorscaled to time, e.g., as shown in FIG. 11. As further shown in FIG. 11,a thumbnail 1202′ may further include details regarding a beginning(entry) of a session and an end (exit) of the session.

Population Repository

In an example embodiment of the present invention, results of a patienttherapy are transferred to a remote repository, e.g., a remoteprogrammer system or a remote database, such as through a network orother communication method. In certain examples, the patient's results,as well as the results of one or more other patients, are collected,stored, or analyzed using the remote programmer system or the remotedatabase, for example, to create patient population information. Incertain examples, the population information can be used to update orotherwise program the clinician programmer system. For example, theinformation can be used for populating a library of VOAs andcorresponding parameters, and/or for generating brain atlases.

Additional Notes

All publications, patents, and patent documents referred to in thisdocument are incorporated by reference herein in their entirety, asthough individually incorporated by reference. In the event ofinconsistent usages between this document and those documents soincorporated by reference, the usage in the incorporated reference(s)should be considered supplementary to that of this document; forirreconcilable inconsistencies, the usage in this document controls.

The above description is intended to be illustrative, and notrestrictive. Those skilled in the art can appreciate from the foregoingdescription that the present invention may be implemented in a varietyof forms, and that the various embodiments may be implemented alone orin combination. Therefore, while the embodiments of the presentinvention have been described in connection with particular examplesthereof, the true scope of the embodiments and/or methods of the presentinvention should not be so limited since other modifications will becomeapparent to the skilled practitioner upon a study of the drawings,specification, and following claims.

1. A method of a volume of activation (VOA) providing machine to providea VOA of a stimulation electrode leadwire, comprising: calculating, by aprocessor of the machine, a VOA for each of a plurality of sets ofparameter settings of the leadwire; storing in a database each of thecalculated VOAs in association with the respective set of parametersettings for which it was calculated; obtaining a further set ofparameter settings of the leadwire; determining, by the processor, a VOAfor the obtained set of parameter settings based on the stored VOAs; andoutputting, by the machine, the determined VOA.
 2. The method of claim1, wherein: the further set of parameter settings includes a pluralityof sets of parameter settings for a therapy that includes performing astimulation using the plurality of sets in a sequence; the calculatingof the VOA includes calculating a respective VOA for each of theobtained plurality of sets; and the outputting of the determined VOAincludes playing back the plurality of calculated VOAs as a movie. 3.The method of claim 1, wherein: the further set of parameter settingsincludes a plurality of sets of parameter settings for a therapy thatincludes performing a stimulation using the plurality of sets in asequence; the calculating of the VOA includes calculating a respectiveVOA for each of the obtained plurality of sets; and the outputting ofthe determined VOA includes: displaying selectable componentscorresponding to the plurality of calculated VOAs according to thesequence; and in response to selection of one of the components,outputting the calculated VOA that corresponds to the selectedcomponent.
 4. The method of claim 1, wherein the obtained set ofparameter settings is different than all of the stored sets of theparameter settings.
 5. The method of claim 1, wherein the determining ofthe VOA for the obtained set of parameter settings includes determiningwhich one or more of the stored sets of parameter settings are mostsimilar to the obtained set of parameter settings, and selecting a VOAcorresponding to the one or more stored sets of parameter settings. 6.The method of claim 5, wherein the one or more stored sets of parametersettings includes a plurality of sets of parameter settings for whichdifferent VOAs were calculated, and the selection of the VOA includesconstructing a new VOA based on features of the different VOAs.
 7. Themethod of claim 6, wherein: the calculating step includes, for each ofat least one parameter setting, calculating a respective set of VOAs fora range of parameter values for the parameter setting, parameter valuesof other parameter settings of the set remaining the same for thecalculation of the respective set of VOAs; the method further comprises,for the each of the at least one parameter, developing a relationship ofa variance in a value of the parameter to a variance in a VOA; and theconstruction of the new VOA is performed based on one or more of thedeveloped relationships.
 8. The method of claim 7, further comprising:storing in the database the new VOA in association with itscorresponding set of parameter settings.
 9. The method of claim 1,further comprising: developing a parameter set-to-VOA relationship basedon the calculated VOAs, wherein the determination of the VOA for theobtained set of parameter settings is based on the developedrelationship.
 10. The method of claim 1, wherein each set of parametersettings includes a setting for at least one of a leadwire location, anelectrode location, a selection of one or more electrodes foractivation, a stimulation current amplitude, a stimulation frequency, animpedance, and a pulse width.
 11. The method of claim 1, wherein theoutputting of the determined VOA includes displaying the VOA overlaid ona representation of brain tissue and a representation of the leadwirepositioned in the representation of the brain tissue.
 12. The method ofclaim 1, wherein the stimulation electrode leadwire provides a deepbrain stimulation under the obtained set of parameter settings.
 13. Amethod of a volume of activation (VOA) providing machine to provide aVOA of a stimulation electrode leadwire, comprising: receiving, by aprocessor of the machine, user selection of a plurality of points withinone of a displayed two-dimensional plane and a displayedthree-dimensional volume, the plurality of points defining a targetactivation region; responsive to the receipt of the plurality of points,determining, by the processor, an estimated VOA for the targetactivation region and leadwire parameter settings corresponding to theestimated VOA; and at least one of (a) displaying the estimated VOA, (b)programming the leadwire with the parameter settings, and (c) outputtingthe parameter settings.
 14. A system for providing a volume ofactivation (VOA) of a stimulation electrode leadwire, comprising: amemory device; a display device; and a processor configured to:calculate a VOA for each of a plurality of sets of parameter settings ofthe leadwire; store in the memory device each of the calculated VOAs inassociation with the respective set of parameter settings for which itwas calculated; obtain a further set of parameter settings of theleadwire; determine a VOA for the obtained set of parameter settingsbased on the stored VOAs; and display in the display device thedetermined VOA.
 15. The system of claim 14, wherein: the further set ofparameter settings includes a plurality of sets of parameter settingsfor a therapy that includes performing a stimulation using the pluralityof sets in a sequence; the calculation of the VOA includes calculating arespective VOA for each of the obtained plurality of sets; and thedisplay of the determined VOA includes playing back the plurality ofcalculated VOAs as a movie.
 16. The system of claim 14, wherein theobtained set of parameter settings is different than all of the storedsets of the parameter settings.
 17. The system of claim 14, wherein thedetermination of the VOA for the obtained set of parameter settingsincludes determining which one or more of the stored sets of parametersettings are most similar to the obtained set of parameter settings, andselecting a VOA corresponding to the one or more stored sets ofparameter settings.
 18. The system of claim 17, wherein the one or morestored sets of parameter settings includes a plurality of sets ofparameter settings for which different VOAs were calculated, and theselection of the VOA includes constructing a new VOA based on featuresof the different VOAs.
 19. The system of claim 14, wherein: thecalculation of the VOA includes, for each of at least one parametersetting, calculating a respective set of VOAs for a range of parametervalues for the parameter setting, parameter values of other parametersettings of the set remaining the same for the calculation of therespective set of VOAs; the method further comprises, for the each ofthe at least one parameter, developing a relationship of a variance in avalue of the parameter to a variance in a VOA; and the construction ofthe new VOA is performed based on one or more of the developedrelationships.
 20. The system of claim 14, further comprising:developing a parameter set-to-VOA relationship based on the calculatedVOAs, wherein the determination of the VOA for the obtained set ofparameter settings is based on the developed relationship.